Text

Semiannual Rept,Mar-Aug 1978, for Coratomic C-100 Series radioisotopic-powered Cardiac Pacer Clinical Implant Program for SNM-1319
	ML19281A129
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Site:	07001342
Issue date:	01/23/1979
From:	; BIOCONTROL TECHNOLOGY, INC. (FORMERLY CORATOMIC
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{{#Wiki_filter:. CORATOMIC C-100 SERIES RA310lSOTOPIC POWERED CARDIAC PACER CLINCAL IMPLANT : PROGRAM l Eighth Semi-Annual Report for the period March 1,1978 to August 31,1978 Presented to the UNITED STATES NUCLEAR REGULATORY COMMISS!ON 2:ery 790306058]

TABLE OF CONTENTS Subject Purpose of the Investigational Program 1 Isotopic C-100 Series Pacers Forty-Eighth Month 2 Clinical Status Reference Control Group Status 6 Comparison of C-100 Series and Control Group 6 Patients' Age Comparison 7 Patient Follow-Up Contact 7 Accountability 9 LIST OF ILLUSTRATIONS Figure 1 - Accumulation of Implants Per Month 3 Figure 2 - Patient Age Distribution 8 LIST OF TABLES Isotopic C-100 Series Pacemakers Table 1 - Itemization of Implanted C-100 Pacemakers 10 Table 2 - Itemization of Implanted C-101 Pacemakers 15 Table 3 - Itemization of Lead Placement - C-100 Pacemakers 28 Table 4 - Itemization of Lead Placement - C-101 Pacemakers 33 Table 5 - Itemization of Identification and Contact Being 46 Maintained - C-100 Pacemakers Table 6 - Itemization of Identification and Contact Being 50 Maintained - C-101 Pacemakers Table 7 - Explanation of Post-Implantation Complication 63 C-100 Pacemakers Table 8 - Explanation of Post Implantation Complication 65 C-101 Pacemakers Table 9 - Itemization of Explants - C-100 Pacemakers 68 Table 10 - Itemization of Explants - C-101 Pacemakers 70 Conventional Powered Pacemakers - Control Group Table 11 - Itemization of Implanted Conventional Powered 72 Pacemakers Table 12 - Itemization of Lead Placement 78 Table 13 - Explanation of Post-Implantation Complication 83 Table 14 - Itemization of Explants 84

e This is the eighth semi-annual report to be presented to the Nuclear Regulatory Commission on the clinical per-formance of the Coratomic C-100 Series Radioisotope Powered Cardiac Pacemaker, as required by license number SNM-1319. This progress report contains the 48 month status of the clinical program from September 1, 1978 to August 31, 1978. All data contained within includes the above four year time span. PURPOSE OF THE INVESfIGATIONAL PROGRAM The purpose of the Investigational Program is to determine the efficacy, longevity and statistical reliability of the C-100 Series Pacers using a 90% confidence testing criterion. The objective is to provide greater longevity compared to non-isotopic pacers and prolonged relief from the consequences of symptomatic bradycardia for those patients receiving the C-100 Series Pacers. The C-100 Series Pacers are R-wave inhibited demand pacers powered by the oxide form of Plutonium-238. Due to the long life of the power source, these pacers have a mean calculated longevity of 77 years.

2 ISOTOPIC C-100 SERIES PACERS FORTY-EIGHTH MONTH CLINICAL STATUS A total of 377 Coratonic Isotopic Cardiac Pacemakers have been implanted in humans since the beginning of the clinical program in September, 1974. An analysis of implants by model shows 93 C-100 implants with 284 implants using pacer model C-101. Human implants during the eighth report period have totaled 30. Figure I graphically illus-trates average implant frequency during the seven initial report periods as well as the average monthly accumulation of implants for the eighth recort period. Implants have occurred in 82 hospitals licensed by either the Nuclear Regulatory Commission or the corresponding agreement state. The availability of Coratomic Isotopic pacers has increased as a direct result of the increase in participating hospitals. Implants are now occurring as far north and south as Michigan and Florida and as far east and west as Massachusetts and California. Status of the Investigational Program shows a total of 377 Isotopic human implants with 38 explants (10.1%). Seventeen of the explants involved pacer model C-100 with twenty-one model C-101 explants. Of the 38 pacers removed, 17 (4. 5%) were attributed to patient deaths. For a further explanation as to the reasons for pacer removals, see Tables 9 and 10. Tables 1 and 2 list the number of days of pacemaker service until removal. The 38 pacers removed

8 F5 I: M i 3 Ss T E: N L E: A P HT 3 E A N L O 5 O M I 7 R 73 EP M A S R G T O N R g' k o,N I xz hsM P A L L h A t P 7 E C P I M IL e i C r D uF ig F O u O R h O F t =S s E N P H O T xx k o,M N I D T O O A h R t L 5 E P U x /ak M U 0 4 h C R t = 4 E C P A ll o, D O dr R A 3 E P ,W D 2 O 4 dn R = 2 E P D o, O ts R l E P - ~ - - n

4 have been returned to Coratomic for extensive testing. Test results showed 34 of these pacers to be operating within specifications when returned. One pacer was not in specification due to fracture of a wire connecting the isotopic battery to the electronic circuit. This resulted from a random manufacturing failure of a silicone rubber support mechanism whien did not cure completely during production. This has been traced to error in mixing the rubber. All applicable production personnel have been informed of this random failure to mix, and an automated mixing procedure was instituted immediately after this pacer was examined. As part of Coratomic's routine manufacturing audit, 95 isotopic batteries were disassembled and investigated during the previous 48 months. In each of these batteries, the silicone rubber support mechanism was found to be functional. A second pacer was found to operate intermittantly at its noise rate when returned. This was due to random failure of a solder joint. A third pacer was not operating in specifications when returned, and this was traced to an intermittant short-circuit failure in the pacer's DC-DC converter transformer. The failure was due to the highly unlikely coincidence of dual flaws in the enamel insulate of both primary and secondary windings. No other failure of a transformer has been seen in Coratomic's experience with over 300 isotopic pacer circuits, in varied stress environments.

5 A fourth pacer was returned to Coratomic for analysis after a suspected deviation from specifications. This deviation could not be duplicated by extensive testing at Coratomic. However, destructive examination of the pacer indicated the presence of a foreign wire fragment which could possibly have caused the reported deviation. The good manufacturing practices observed at Coratomic make the inclu-sion of such a foreign particle highly unlikely, and are expected to prevent repetition of this type of problem. Like the second pacer discussed above, a fifth pacer was found to operate intermittently at its noise rate, again due to random failure of a solder joint. This is the second solder joint failure observed in approximately 9,000 unit months of implant experience. Each isotopic pacer has approximately 150 solder joints, so nearly 980 million hours have been accumulated on these joints, with only two failures. This yields a failure rate of 2.0 per billion hours, which is less than the expected value given for high reliability solder joints in the Air Force's Reliability Handbook, MIL-HDBK-217B. The two initial C-100 human implants, performed on October 3, 1974, continue to pace the patients satisfactorily and have accumulated unit implant time of 1427 days (46.9 months). The clinical program has accumulated 8977 unit months, with an average implant time of 23.8 months--(Model C-100 at 3324 months, Model C-101 at 5653 unit months). Tables 1 and 2 give a further breakdown of pacer implant time for models C-100 and C-101 respectively.

6 Pacer number 1N030133 was explanted on November 26, 1976, refurbished and implanted again on March 28, 1977. The first implant is listed under "C-101 Pacemakers No Longer In Service," and the refurbished pacer appears in the section "C-101 Pacemakers In Satisfactory Service." REFERENCE CONTROL GROUP STATUS Data on the Control Group continues to be collected by Coratomic as required by license and as referenced in the Human Clinical Protocol for the C-100 Series Pacer. Reports on 105 control patients were on file at Coratomic as of August 31, 1978, with attempts at obtaining additional control patients in process. The data collected thus far reveals 14 conventionally powered pacemakers (13%) are no longer satisfactorily pacing the patients in the control group. Of the 14 pacers no longer in service, five (5%) are attributed to patient deaths. For explanation of each pacer servic'e termination see Table 14. The Control Group as a whole has a cumulative unit implant time of 3936 months with an average implant time of 37.5 months. Table 11 lists the individual implant time in days or the number of days of pacemaker service until removal. COMPARISON OF C-100 SERIES AND CONTROL GROUP The observed failure rate of C-100 Series Pacers, with 5 failures in 8977 unit months, is 0.06 percent per month. At 90% confidence, it is 0.10 percent per month. The observed failure rate of control group pacers, with at least 6 failures in 3936 unit months, is 0.15 percent per month. At 90% confidence, it is 0.27 percent per month.

7 PATIENTS' AGE COMPARISON The ages of the patients selected for implantation of the C-100 Series Pacers have a distribution of 9 months to 81 years with a range of 80 years. The average and median of the isotopic implant age distribution are 49 and 54 years of age respectively. Of the 377 human implants, 43% are females with 57% of the C-100 Series patient population being males. The average age of the females is 46.2 years with the male implant patients being somewhat higher at 50.8 years of age. Similar calculations for the Control Group show a range of 73 years. The average and median of the overall group is 62 years and 64 years respectively. Break-down of the non-isotopic powered implant group by patient sex shows 32% being females with an average age of 61.6 years and 68% being males with an average age of 62.0 years. The age difference between the two groups, particularly the average age is due primarily to the long expected life of the Coratomic isotopic pacemaker, therefore, producing a selection of younger patients. Figure 2 graphically illus-trates the patient age within the two groups and defines the overall percentage of females and males within each ten year age interval. PATIENT FOLLOW-UP CONTACT Presently, implanting institutions report adequate follow-up contact being maintained, in accordance with the C-100 Series Clinical Protocol, with 61% of the C-100 Series

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9 implant patients, allowing for a six-month lag in receiving follow-up information. Through the efforts of the physi-cians involved and Coratomic, attempts are being made to maintain timely contact with all C-100 Series implantees. Action currently being instituted includes the steps outlined in the C-100 Series Clinical Protocol. In addition, Coratomic's Patient Records Department is continuing to use the latest information on maintaining patient contact available from registration or follow-up reports. ACCOUNTABILITY There have been 377 human implants at 82 of the 113 licensed hospitals. All of the pacemakers have been accounted for during the report period; thus producing a total accountability of 100%.

TABLE 1 1MZATICU OF DTIR.TED C-100 PIC7JIPS STICAL DTIR?"I'?G ACE Cr ELTATICN CF F.'.C72 IGGER CMT C? DGTTILTICd CTC CP PATE.T SET!/ ICE (it; days) l-(coded) 170.LTI,%-73 (coded) DTI.72.T AT DTUJ.T CA2 CF F;20.T C-100 PIC7dEFS DI SATISF7CCF2 SG/ ICE N001027 10-25-74s 001 12-11-74 65 1,358 N001028 09-16-74 001 11-01 74 59 1,398 N001029 03-23-74 001 11-21-74 61 1,378 N002030 03-28-74 002 l0-03-74 63 1,427 N002031 11-20-74 002 05-13-75 61 1,205 N002033 09-04-74 002 10-03-74 61 1,427 { N002035 09-16-74 002 10-24-74 57 1,406 N002036 09-17-74 002 10-25-74 64 1,405 N002038 09-30-74 002 10-22-74 68 1,408 N003040 11-05-74 003 11.18-74 51 1,381 N006041 10-28-74 006 01-09-75 62 1,329 N001042 10-02-74 001. 11-01-74 22 1,398 N002043 10-23-74 002 12-04-74 69 1,365 N002044 10-23-74 002 12-10-74 63 1,359 N002045 10-21-74 002 11-29-74 64 1,370 N002046 10-22-74 002 i 11-11-74 69 1,388 N001047 10-23-74 001 <12-13-74 62 1,356 (' N002049 10-24-74 002 12-05-74 65 1,364 N001050 10-28-74 001 12-20-74 52 1,349 N003051 11-08-74 003 11-22-74 5; 1,377 10

'D2:2 1 ITDE'llCIQ1 CF DTU2TI"JD C-100 PIC7&SS SERT.AL D T I.;e c t :G AC OF EUFIC!G2 CF T/ C D.'s };G G E R CIC CF D:S"TILTICU D'CE CF PACC SFR7!C (i". i p; I (ccded) ! M TIC EIC (coded) 2TDJC AT DTIRC CICE CF Fd~ CIC s C-100 PTC763 ri SA~'IEF7CCM hv'C N003055 11-12 74 003 01-28-75 68 1,310 N003056 11-08-74 003 l2-05-74 66 1,364 ~ N003057 11-13-74 003 12-31-74 22 1,338 N003058 11-14_74 003 02-03-75 64 1,304 N003059 11-14 74 003 02-07-75 31 1,300 (' N006062 11-20-74 006 04-13-75 63 1,235 N004064 11-21-74 004 01-08-75 24 1,330 N005078 02-06-75 005 03-18-75 56 1,261 N001091 01-29-75 001 02-19-75 53 1,288 N001093 01-31-75 001. 32-05-75 53 1,302 N005095 01-31-75 005 32-10-75 16 1,297 N005096 02-07-75 005 35-16-75 61 1,202 N008098 02-05-75 008 33-03-75 39 1,276 N000100 02-12-75 008 33-24-75 34 1,255 N011101 02-13-75 011 03-04-75 13 1,275 N007103 02-18-75 007 28-13-75 62 1,113 N014105 02-14-75 014 23-27-75 22 1,252 N008106 02-18-75 008 .35-16-75 53 1,202 N007109 03 ;4-75 007 11 34-14-75 63 1,234

E 'ITL I?E 1 ITaESTICZi G DTUerI"JD C-100 PIC7J223 SERIAL E S LA h" D T~, ACC CF CUPATIGI CF P.'.T/'. !ETIR CE C" 2:ST1"LTIC! CM CP PATID.T SE?/IC (in i.72) (coded) !?lEACILTd~. (coded) DTI.12.T AT n2I.Al.T m'"E CF E.C' C-100 PIG 74'.S IN STCISF;c:Oru* SEIUICE N012110 03-13-75 012 04-26-75 06 1,222 N001111 03-14-75 001 04-25-75 6a 1,223 N001113 03-17-75 001 04-28-75 6a 1,220 N012114 03-31-75 012 04-251-75 16. 1,219 N00ll17 03-31-75 001 35-07-75 45 1,211 N01.3118 03-3k-75 313 35-07-75 26 1,211 ( N00ll19 03-31-75 001 ]7-21-75 51 1,136 ( N001120 03-31-75 001 37-03-75 67 1,154 N020122 03-31-75 020 05-05-75 .13 1,182 N003126 04-23-75 003 37-11-75 62 1,146 N015128 04-04-75 015 37-07-75 27 1,150 N005129 04-14-75 005 39-04-75 25 1,091 N005130 04-14-75 005 10-23-75 22 1,042 N009133 04-14-75 009 37 02 75 22 1,155 N009134 04-23-75 009 37-03-75 18 1,154 N001135 04-14-75 001 37-25-75 65 1,132 N001136 04-23-75 001 27-10-75 61 1,147 N017137 05-07-75 017 39-05-75 40 1,090 N0_0ll38 04-23-75 001 28-07-75 58 1,119 i N00ll39 04-30-75 001 28-22-75 52 1,104 ( N020142 04-23-75 020 27-28-75 24 l 1,129 NO21144 05-06-75 021 28-06-75 48 1,120 12

3 M1 ITDEZATICN CF DTUt/I~ED C-100 PIMIJ2PS SERLE D P UlC r4G AC CF CLTATICN CF PJ.'.?_ NLISER CATE C" 2.5Tr 2 !CN CTC CF PATEC ORC (i:. d:, ;! (ccded) F9.VJJCICIE (ccdcd) DMIC AT DTUM CTC CF TE OTC C-100 PACHWHS ri SATISF;cICRI SEWI2 N022145 04-30-75 022 08-07-75 65 1,119 N001146 05-06-75 001 08-22-75 GG 1,104 N001147 05-07-75 001 CR-10-75 73 1,085 N023150 05-06-75 023 08-27-75 65 1,099 N012152 05-14-75 012 07-10-75 IG 1,147 N001156 05I4-75 001 09-12-75 65 1,084 N001157 05-14-75 001 09-17-75 60 1,078 ( NO24159 05-16-75 024 09-05-75 18 1,090 N022160 05-14-75 022 09-10-75 71 1,005 N001161 05-14-75 001 09-22-75 24 1,073 N020162 05-16-75 020 09-14-75 46 1,081 N001166 05-22-76 001 01-29-76 61 944 N003168 05-29-75 003 10-07-75 52 1,058 N003169 07-31-75 003 10-06-75 23 1,059 N004170 05-22-75 004 09-27-75 51 1,068 l,. e 13

TJCIE 1 ITi21I7ATIGI OP 119IAvrED C-100 P//TNJ335 SEPJAL TTJI?J7PITlG trd OF DJPATIO C7 PJ 'E 1;ti S E R D'.';7 C ..',ird;1'FN C'.TE OF PATTI27f SE!UICE {.ia d..y:- (co: lod) I'J2!U17CE11 i (c;CW) I?. fil?i' AT IGFZP CA'"3 CF FZGC l C-LOO I'7.Ci'".' f mS 50 I.0:;GER IN SERVICE fl001032A 09-04-74 001 11-04-74 35 612 N001034A 09-04-74 001 10-11-74 60 1,103 i N001039A 10-17-74 001 12-13-74 55 085 N00304CA 10-30-74 003 11-07-74 69 1,126 N00.2052A 10-24-74 002 12-06-74 68 947 N002053A 10-25-74 002 03-14-75 63 1,024 N003054A 11-13-74 003 12-02-74 57 091 N0010928 02-07-75 001 04-21-75 54 991 N004097A 02-05-75 004 02-19-75 57 003 N008099A 02-08-75 008 03-10-75 42 040 N005102B 02-14-75 005 06-10-75 26

461, N002108B 03-14-75 002 07-10-75 67 099 11001121.B 03-31-75 001 05-14-75 66 163 N0211430 04-23-75 021 07-30-75 59 042 N021149B 05-06-75 021 08-21-75 53 020 N001163B 08-21-75 001 09-23-75 63 1,073 N004167B 06-26-75 004 09-25-75 64 261 14 7

T;eL: 2 TIDC*/ATIOi CF E:PIR.TCD C-101 PICII",4'. G U SEPJAL D!PTREltC ACC OF DEATICI CF F.'.72'? !."J'.D7. DY.2 CF EGTI"LTIUi C/.TC CF PICC n 'IC (in c:'.:a (@A) .9sGJF7CliE (coded) DtPIRC /C D'PIRC IWIE CF irc e C-101 PICDWIPS El SATISF?CIOl s'IC 1N001001 08-21-75 001 09-29-75 72 1,066 1N002002 06-25-76 002 10-17-75 67 1,048 1N015003 07-10-75 015 08-21-76 43 740 1N021004 07-10 7! 021 12-10-75 59 1,069 1U002005 10-3r-75 002 01-21-76 72 952 1N001006 07-10-75 001 10-13-75 55 1,052 4 1N027007 09-25-75 027 10-23-75 70 1,042 i' 1N001008 03-17-76 001 06-09-76 60 813 1N021010 07-10-75 021 09-10-75 53 1,085 1N026011 08-21-75 026 10-02-75 34 1,063 I 1N001012 07-13-75 001 09-29-75 16 1,066 IN035013 10-30-75 035

e.01-05-76 58 968 1

1N029015 05-07-76 029 11-05-76 20 664 1N003018 08-28-75 003 08-20-76 06 836 1N003019 08-21-75 003 Id-24-75 64 1,041 1N001022 07-24-75 001 10-10-75 56 1,c;5 1NO34023 11-19-75 034 01-20-76 55 953 1N031024 03-14-75 031 10-24-75 59 1,041 IN029025 09-17-75 029 02-13-76 20 919 AN028026 09-11-75 02S 10-27-75 11 1,038 l 1N023028 08-14-75 023 11-10-75 66 1,024 15

1 Tid 3:2: 2 IIDIIZlC::CN CF DTUJIICD C-101 PI'.CD70'ETS SERIAL D T UCE'D;G IC OF CL'I%T!CU CF P'.T;T.' !D:EER mTE CF E.5'~rnf I'Ju Er.2 Or, IwTU:tr SER/IC- (6 i:yc; (ccded) W#JDL7Ji~5 (coded) HTUCC A? DTU.2C r.;CE C::' F T r C-101.lC W'ETG IN F/CISTl C W SCFJ/ ICE 1N003029 08-14-75 003 07-06-76 Unknown 786 1N001033 03-28-75' 001 11-24-76 61 1,010 1N027031 08-14-75 027 01-31-76 75 942 1N028032 08-28-75 028 11-03-76 49 1,031 1NO37033 09-17-76 037 11-10-75 14 1,024 1N046034 08-26,76 046 g05- 01-76 66 852 IN002035 08-28 76 002 31-09-76 63 964 r 1N00203s 09-11-75 002 12-16-75 75 988 9 1N002037 09-17-75 002 11-25-75 63 1,009 1NO31039 09-25-76 031 11-07-75 61 1,027 1N007040 09-17-75 007 11-10-75 61 693 1N025041 09-24-75 025 37-30-76 48 762 1N007042 09-25-75 007 12-03-75 53 1,001 1N038043 01-08-76 038 J2-03-76 51 939 1N053044 09-25-76 053 36-01-76 68 821 lE001045 09-25-76 001 12-04-75 59 1,000 1NO32046 10-30-75 032 1?-05-75 43 999 1N007047 10-10-75 007 31-13-76 18 960 1NO30048 02-13-76 030 34-07-76 80 876 ( 1N001049 09-25-75 001 3 )l-21-76 55 961 1N075050 12-02-75 075 '09-03-76 36 727 18014051 09-30-75 014 k2-09-75 59 995 1NO34052 09-30-75 034 16 989 j 16 j2-15-75 j g

tam.c 2 ITEMI2ATICM CF D'PUe,7D C-101 PIC2WCS SEPJAL IMPUJ.TUC /C OF [7JPATICI CE FTC - !D ELG D*sTE CF E.'STIT C CU DC CP PA312.T S S-ICE (ir. d aa. (coded) !O2.tTICLTC (coded) E TUJ,7 ' AT D'PUJ,7 U,TE CF IC"GT C-101 PIO NUS D1 FATISFTCt2 m* CE 1N011053 09-30-75 011 02-07-76 11 95 1N054054 10-30-75 054 05-24-76 22 829 1NO36055 10.10-75 036 01-20-75 59 953 1N001056 01-15-75 001 03-12-76 36 902 1N027057 01-15-76 027 02-17-76 57 925 1N028058 10-10-75 028 12-22-75 57 982 t, lu018059 10-23-75 018 12-23-75 34 981 1N050060 10-29-75 050 05-14-76 43 849 1N049061 02-19-76 049 04-13-76 38 870 1N061063 11-17-75 061 07-16-76 23 776 1N023064 10-30-75 023 01-23-76 68 950 1N003065 l 10-30-75 003 12-29-75 23 975 1N030066 10-30-75 030 02 13-76 72 929 1N001068 06-11-76 001 08-13-76 51 748 1N007069 11-12-75 007 04-14-76 58 869 1N038070 10-30-75 038 01-23-76 52 950 IN041071 12-01-75 041 06-13-76 2 809 1N027073 11-11-75 027 02-25-76 68 937 1N044074 11-11-75 044 03-10-76 63 904 ( 1N002075 11-11-75 002 08-09-76 68 752 1N002076 11-11-75 002 36-21-76 73 797 1N001077 11-11-75 001 J1-30-76 65 943 1N024078 11-19-75 024 17 31-30-76 10 943

TABLE 2 ITEMIZATICI CF IMPIRIIdD C-101 PIC7&.rG SErJAL D9IR.TR C /C CF DUPATIC'; CP Ft. T.I. NilCI.R DiT CF O 2iT m T !CII L' T" CF PATII:7.' SE.WIC (ir, cLws j, A (ccded) M/c!UFAOn."2 (ctxted) ETIR.T AT !PPIR.T C/C CP FO.UC C-101 PIC77d22S 21 St,T'.SP/CICIE SE/ ICE 1N001079 11-19-75 001 02-23-76 62 919 1N072080 12-16-75 072 10-18 76 38 682 1N009081 1.1-19-75 009 01-05-76 2a 937 1N047082 07-30-76 047 10-07-76 68 693 1N038084 01-08-76 038 02-23 76 35 939 1N027086 01-15-76 027 02-12-76 72 930 1N095087 11-17-75 095 09-15-76 2a 715 ( 1N023088 01-08-76 023 08-30-76 65 731 1N004089 06-24-76 004 06-28-76 52 794 lNO30090 01-15-76 0;s 03-02-76 67 912 1N001091 10-30-76 001 01-05-77 48 603 1N023092 01.08-76 023 03-26-76 63 888 1N040093 01-08-76 040 03e04-76 13 '910 1NO39095 01-15-7G 039 02-13-76 52 929 1N095098 08-05-76 095 09-14-76 24 716 1NO34099 04-21-76 034 35-25-76 61 828 1N041100 01-22-76 041 02-17-76 05 925 1N047102 01-15-76 047 33-25-76 73 889 l-1N046103 01-22-76 046 24 09-76 48 874 1N048104 12-18-75 048 34-16-76 2.1 867 1N002105 02-03-76 008 !1-03-76 5G 666 18

T11'L 2 ITCtI"JTICN CF D'.PUJ!"O C-101 PICC7JE SERJAL Y DOUJTTRG IG OF [UPATIC: CF P.'.C? ?-

2. W.N 21 D'C C" 20C.rICc:

CN"C Gr, P7CIFJC SZ.R/ICZ (r. cwal (codcd) .?2.~EAC UTC (cx2ded) DEU C AT DTI/JO C'C OF GCC C-101 PICDA!W 21.VCSFt.CCRI :-cc.CCE 1N089106 02-19-76 089 02-10-77 08 567 1M056108 12-22-76 056 04-14-76 6d 869 1!1145110 01-05-76 145 12-15-77 55 259 1N029111 12-1S-75 029 08-2.7-76 0413 734 1N004112 04-22-76 004 09-03-76 62 727 1N030ll3 12-10-75 030 06-07-76 26 815 ( 1N001114 12-22-75 001 03-24-76 25 890 i 1N042115 01-05-76 042 03-JS-76 27 896 1N009116 04-14-76 009 05-?1-76 28 832 1N001117 01-05-7G 001 G6-07-76 49 815 lN001118 01-06-76 001 34-29-76 42 854 1M047119 02-04-76 .047 11-04-76 66 665 1N040121 01-13-76 040 33-23-76 19 891 1M023122 01-12-76 023 33-73-76 69 885 1N043123 01-13-76 043 33-26-76 58 888 1N027124 03-01-76 027 24-07-76 75 876 1N072125 07-08-76 072 17-29-76 28 763 1N052128 03-01-76 052 15-20-76 35 833 ( IN045129 03-17-76 045 14-03-76 55 aan 1N001130 03-30-76 001 06-L1-76 54 811 1N00ll31 05-10-75 001 06-25-76 58 797 li4025132 04-27-76 025 39-23-76 29 m 19

TicLC 2 I'ID!IZATICri CF rIPUd.TCD C-101 PlcWTJS E7JAL DiPINCItG /CE OF CUPATICI CF T J.I.'. 1.Ur.dEit DA""E CF DST"?J'IC*; C

T.' CF PATE.7C SERC TZ (in C.:yc (coded)

WJ.~uTTCILTC (c::cied) DTIRC /C IPPUdtr IfC2 CF ICFO!C' C-101 PICDWTlG El SATI5FIC CIU ECCE lu030133 01-31-77 030 03-28-77 66 521 IN002134 07-08-76 002 09-10-76 68 720 1N026135 03-29-76 026 06-11-76 36 811 IN061137 03-29-76 061 12-13-76 47 626 1N072138 03-30-76 072 07-26-76 67 766 1N052139 06-24,76 052 11-12 76 60 657 1N023140 03-25-76 023 06-7.7-7E 73 800 AN057141 03-30-76 057 05-27-76 50 826 1N073142 04-06-76 073 )9-28-76 36 702 1N008143 C9-15-76 008 ',0-25-76 54 675 1N046144 04-24-76 046 05-21-76 21 832 1NO30145 12-18-76 030 01-14-77 66 594 1N051146 04-12-76 051 05-20-76 39 833 1N048147 06-08-76 048 09-10-7G 48 720 1N007148 04-07-76 007 05-19-76 32 834 1N034149 04-08-76 034 G5-14-76 49 839 1N00ll56 05-26-76 001 07-15-76 60 777 1N012151 06-07-76 012 08-04-76 04 757 1N055152 04-22-76 055 06-04-76 27 818 ( IN041153 05-04-76 041 06-23-76 14 799 1N062155 05-11-76 062 09-27-76 47 703 1N097156 05-18-76 097 11-15-76 53 654 INO39157 04-29-76 089 20 08-25-76 57 736 [

TABLC 2 ITDi!ZATIG1 CF DTUJ.TCD C-101 PIC7J3G CEP.IAL DTUd. TING ACE OF DJPATIQ CF "' ~ 1.UCER mTC C" E STITL'!TQ CATI' CF PATIE:.? SFjuvCE (b ci-M l (ccrt:d) !'/J."J;CtHC (codcJ) EtPUC.T ~ AT DTU2.T UGE CF ETCr C-101 PIC7dC'S DJ FIG ~3FlC'?DTW SER/ ICE IN047158 05-17-76 047 10-08-76 62 ~ 692 INO30159 05-18-76 030 11-01-76 63 668 1N001160 05-06-76 001 07-08-76 37 784 1N083161 05-03-76 083 07-07-76 61 785 1U056163 05-13-76 056 08-06-76 26 755 1NO30164 07-06-76

030, 11-18-76 66 651 1N001165 05-19-76 001 08-05-76 53 756 IN055166 05-20-76 055 07-21-76 48 771 10004167 05-20-76 004 08-30-76 54 731 1N077169 05-24-76 077 07-22-76 57 770 1N041170 05-21-76 041 29-76 06 701 1N002171 06-03-76 002 39-20-76 65 710 1N059173 05-25-76 059 10- 7-76 57 683 1N048174 06-22-76 048 11-17-76 46 652 1N095175 07-03-76 095 22-03-77 50 574 i

l!!B5?lM &8:2/.i!6 5 892 2:25W6 7 57 22 1N056178 10-30-76 056 '2-03-76 25 636 ) 1N045180 09-14-76 045 09-28-76 52 702 s t { 1N055182 11-29-76 055 2-14-76 40 625 1N014183 12-20-76 014 01-07-77 53 601 1N059134 09-01-76 059

0-19-76 56 681 1N021185 10-01-76 021 21 638 2-01-76 24 P

TABLC 2 ITOIIMTIC21 CF EGl/E) C-101 PACDWTES SCRTAL DT?R. TING ACE OF I7JFATIC t CF FTC:J !aOEi1 CiG CF H5?I'377ICU CATC CP FN IC.T SER/IC2 (i.n cia /c; ! (codcd) PRTJF7CL76 (ccxled) IMPIR,7 AT !?%v?r r';C 07F5GC C-101 PTCDWT!S IN TATISF.'CCITI SER/ ICE 9 1M089186 10-24-76 089 12-08-76 Unknown 631 s. 1N09G187 01-14-77 096 02-03-77 27 574 1N072189 11-30-76 072 02-19-77 74 558 1N099190 11-18-76 099 J2-21-76 40 618 1N055191 12-28-76 055 02-11-77 El 566 1M060192 12-17-76 060 01-05-77 52 603 1N057193 11-18-76 057 J2-27-76 23 612 1N007194 11-15-76 007 12-15-76 19 624 4 1N101195' ,12-28-76 101 01 77 30 580 1N060196 11-18-76 060 12-29-76 60 lN113197 01-18-77 113 02-03-77 58 574 1N029198 12-17-76 029 06-08-77 26 449 1N062199 12-28-77 062 01-17-77 57 591 1N052200 12-17-76 052 01-11-77 55 597 1N005201 12-17-76 005 02-04-77 36 573 lil041204 02-15-77 041 03-07-77 13 542 IN060206 03-18-77 060 04-04-77 53 514 IN041207 03-18-77 041 04-04-77 11 514 IN141208 03-07-77 141 04-06-77 57 512 INO30209 03-16-77 030 04-04-77 56 514 IN002210 04-25-77 002 06-29-77 52 428 Ift030211 03-24-77 030 06-23-77 52 434 ( kffhh$b $$NdY7 bh OkN8-7E 3h ~ 500 . emf 5" 8ABF 891 W H:ff 3s8 IN142216 04-06-77 142 04-27-77 39 491 IN041218 04-11-77 041 04-27-77 13 491 22 g

y s TABLC 2 TID 1L'ATION OF IP.PIRmD C-1.01 PICDW7JG S~PJtsL D 'PI R E D C ICJ: OF DUPATIC'; CF P!/.B iPMdER DiTE G' DISTTIUTICt1 MTE OP PATID C SEIN1C; (in C.,':;; (coded) !WRT.'/CTUI:E (cxxlod) DTIME AT I!?Ud2 M TE CF 15 01T C-101 P7mMTJG It! SNTIsr/cIGr/ sin' ICE IN059219 04-12-77 059 04-29-77 56 489 1N002220 04-26-77 002 06-13-77 55 444 lf1075221 04-12-77 075 05-19-77 41 469 ,ll:107222 04-12-77 107 05-24-77 02 464 1N055223 04-13-77 055 05-12-77 70 476 IN030224 04-29-77 030 07-21-77 60 406 1N002225 04-14-77 002 09-22-77 50 343 1N142226 05-10-77 142 06-20-77 58 437 4 1N101227 05-09-77 101 07-22-77 60 405 IN001229 05-13-77 001 06-15-77 64 442 1N029231 05-10-77 029 06-13-77 10 444 IN017232 05-06-77 017 06-09-77 30 448 1N001233 05-13-77 001-09-23-77 53 342 1N046235 05-12-77 046 06-20-77 49 437 9 a IN029236 05-12-77 029 39-12-77 16 353 1N083237 05-17-77 083 38-19-77 52 377 1N030238 05-17-77 030 38-29-77 72 367 1N002240 07-13-77 002 12-14-77 47 260 1N046241 06-03-77 046 )7-25-77 62 402 IN020242 06-03-77 020 )7-26-77 36 401 IN101243 05-31-77 101 09-12-77 unknown 353 1N046244 06-14-77 046 07-11-77 56 416 23 . -- ~

.Y TABLE 2 N1IZATION OF DHLWDD C-101 PACU"#EPS SERIAL D'PIlmnG AGE OF DUPATIC'1 OF Plc.?: !DZER DA'm 0" D 3TI'itTIG1 D;TE OP PATIUTP SEIUICE (in deja) (ccded) WCJr7CILTE (ccded) DTIR.7 AT 11PIICT DATE OF IEPO.T C-101 PicanKEPs DJ SATIsrtcIOTU CETUICE 1N098245 05-31-77 098 09-13-77 '81 352 1N143246 06-14-77 143 07-12-77 59 415 1N001248 06-16-77 001 01-03-78 58 240 IN052249 06-08-77 052 01-11-78 41 232 1N046250 06-08-77 046 11-25-77 38 279 liiO65251 06-10-77 065 08-10-77 49 386 1N113253 06-26-77 113 08-11-77 41 385 INil3255 06-10-77 113 09-16-77 41 349 1N101256 06-17-77 101 09-20-77 51 345 1N029'257 0 16-77 029 09-14-77 9 351 1N002258 07-01-77 002 11-17-77 57 287 1N029259 06-23-77 029 02-21-78 17 191 IN002200 06-26-77 002 10-14-77 70 321 1N101261-06-24-77 101 10-03-77 48 332 ,4 1N002263 06-24-77 002 10-11-77 72 324 3 1N006264 10-10-77 006 03-21-78 56 163 1N008265 07-05-77 008 02-23-78 41 189 1N141266 07-05-77 141 10-12-77 66 323 IN097267 07-05-77 097 10-18-77 44 31 7 1N002268 07-11-77 002 12-05-77 41 269 1N002269 07-06-77 002 11-15-77 46 289 1N146270 07-25-77 146 01-26-78 58 217 1N002272 07-08-77 002 11-18-77 53 286 1N001273 07-11-77 001 32-27-78 42 185 i 1N144277 07-21-77 144 12-03-77 35 271 1NO36278 07-12-77 036 11-18-77 54 286 24 1 ,,4.*.*T. k

9-TAI 3LC 2 TliXIZATICt1 OF IMPIhn1]) C-101 PICDvmDG. SERIAL IMPIR EING NE OF EURTTIC: OF P7C fT1 SER DTTE OF INSTIR CICU D7sTE OF PATIC C SERVICE (in day: (ctdal) WJ,tTTCPjiC (coded) IMPIRC AT IMPIRC DTsTE OF FCPOP"' C-101 PIGM7JTJ'S It! PJ.TISF/ CIT'R/ TJE7CE 1N003279 07-12-77 003 12-05-77 71 269 1N036281 07-13-77 036 12-05-77 24 269 1N147283 10-24-77 147 03-24-78 74 160 1N059284 07-15-77 059 12-14-77 52 260 1N015285 07-29-77 015 12-08-77 60 266 1N147287 11-03-77 147 04-10 58 143 1N046290 08-03-77 046 06-08-78 60 84 i 1N037291 08-22-77 037 02-20-78 49 192 1N007293 09-29-77 007 04-03-78 30 150 1N002295 08-08-77 002 02-21-78 60 191 1N147298 09-27-77 147 06-30-78 28 062 IN146302 08-15-77 146 02-21-78 57 191 IN029305 08-18-77 029 08-17-78 28 014 1N023306 08-22-77 023 02-24-78 35 188 1N146307 09-08-77 '46 07-06-78 51 056 1N017308 08-25-77 017 02-13-78 41 199 1N147310 , 08-29-77 147 03-07-78 55 ,177 l 1N147311 ' 09-27-77 147 05-30-78 61 093 1 N147312 09-06-77 147 03-22-78 51 162 1N146313 09-08-77 146 07-03-78 49 059 1N145314 09-08-77 145 06-27-78 55 065 1N147317 i 09-08-77 147 08-09-78 65 022 25

y* TAIALC 2 r11XI?/&ICT1 OF IMPINU13).C-101 Plc7tAYJms SEPlAL IMPIR CING /C OF DLTATICN OF P/G. 3ER DiTC OF I?.'STr;UI'IOJ DPsTC OF PATID C SER/ICC (in dag (ccrio.1) MWJPICPJi"2 (otxled) IMPIRC 7T IMPIR?T IVsTC OF RP.Por C-101 PIGMJTJS Ir1 r/.TI.qF/CIOm' 5'R/ICT IN147318 09-08-77 147 08-22-78 57 009 1N147319 09-12-77 147 03-28-78 63 156 1N147321 09-20-77 147 03-22-78 65 162 1N015324 09-29-77 015 05-26-78 63 097 1N147327 10-06-77 147 07-03-78 51 059 1N146328 10-10-77 146 07-06-78 53 056 1N0091001 11-29-77 009 02-22-78 30 190 ( 1N1471002 01-11-78 147 08-17-78 24 014 1N1471003 11-03-77 147 07-11-78 65 051 + 1 l l i I 26 ~

9 TA!n !; 2 r:1;- IT.7/rIa4 OF Iv"Intn1) c-101 P/c7 ArLn; h, i S12IAL T!'P:le7TN; NECF ECPJ C IC; Cr TN. fT.FCLG Loll: CT 8 I;;3TT;'ICri IVC; 0F PATI 12C SER/ ICE (in dr, (cr.bi) "' ':' Th '-" ' 'mela!) I !P!RTT 1 3 L T I R TT IYCE CF ITICTC C-101 PACEMAKERS NO LONGER IN SERVICE 1N001014 09-17-75 001 10-24-75 66 902 1N001020 08-28-75 001 01-23-76 54 137 IN012021 07-31-75 012 09-04-75 09 mos. 245 1N029027 09-11-75 i 029 10-25-75 25 1028 I IN033038 11-17-75 i 033 12-14-75 56 062 IN030062 l01-15-76 030 02-13-76 75 391 I l 1N023067 i10-30-75 023 02-11-76 70 197 i IN001072 l11-11-75 i 001 03-18-76 58 479 ( ( 1N023085 ' 01-15-76 023 02-12-76 68 471 I 1N372096 ' 06-16-76 l 072 08-05-76 74 199 1N023109' I 02-24-76 023 05-02-76 70 838 I INO31120

01-12-76 001 04-06-76 60 164 1N030126

'04-06-76 030 10-21-76 Unknown 21 3 1N072127 03-17-76 072 05-21-76 Uknown 116 1N030133 03-21-76 030 04-13-76 73 227 IN100136 '03-22-76 100 01-08-77 48 427 1N004172 '05-25-76 004 10-01-76 60 094 1N098179 j08-25-76 098 10-02-76 80 346 1N030181 l09-29-76 030 11-03-76 67 095 1N002292

08-04-77 002 01-30-78 61 198 l

IN100297 08-11-77 100 ,03-10-78 49 055 I l

lN03018 Pacer explanted 03-29-76 and reimplanted 08-20-76 e

i i Explant and reimplant not noted in Table 2 implants and explants. 27

TABLE 3 ITDII" TICt! CF III.D PIICDOTE a C-100 P; C F-.PG DuE OF acc Gk uO &M w? h"JD:'R PIC. LETtD IZAD CEECRIITIG' O.EW-l l~lCCT& E ZV-lE C ' '". (CCCED) D? U.'7? PII C ; C.7 (? 7J5: 5:CC"L} DIAL i DUtL C AL DUtL TJ,- C-100 PI C ?u~,~.:G m SATISF7C:OEl SEINICE N001027A 12-11-74 03-03-72 Cordi:; X N001028A 11-01-74 05-06-74 Medtronic 6917 X N001029A 11-21-74 11-21-74 Coratomic L-20 X N002030A 10-03-74 08-29-72 Cordis 62 cm/4m X N002031B 05-13-75 05-13-75 Coratcaic L-10 N002033A 10-03-74 01-21-71 Cordis 62 cm/4m X 2035A 10-24-74 11-16-72 Cordis 62 cm/4cra X 4' .2036A 10-25-74 11-05-72 Cordis 62 cn/4mm X N002038A 10-22-74 10-22-74 Coratcmic L-10 X N003040A 11-18-74 09-15-72 Medtronic 6901 X N006041A 01-09-75 01-09-75 Coratomic L-10 X N001042A 11-01-74 11-01-74 Mcdtronic 6917 X N002043A 12-04-74 12-04-74 Coratcmic L-10 X N002044A 12-10-74 08-24-73 Cordis X N002045A 11-29-74 11-29-74 Coratomic L-10 X N00 :046A 11-11-74 unknown Cordis X N001047A 12-13-74 12-13-74 Coratcmic L-20 I X N002049A 12-05-74 04-10-73 Cordis 62 cm/4m X ^1050A 12-20-74 12-09-74 Medtronic 6917 X N003051A 11-22-74 03-17-72 Cordis X l l t I 28 i i l(

Ti\\BLE 3 ITO'.I".1TICTJ CF IElsD PUCE.7 C-100 PI C 7 ETG inTE CF us;E uF UN :' O /a i R~di ' !RIC 't P7.CCR IT u7 IZAD CIL'.TZICM C.*DD~.An-

.icC&

C.Ts'CJ.- ' "iCC ~. ' - (CCC~D) T1 9 ? R.T PIICU C.i (!*,0 Z 6 2C 0"_*.) l D71 - DILL C'AL D'11 Ce - C-100 PlcNZPS I:1 SATIsr;CCIE SEK/ ICE l N003055A 01-28-75 01-28-75 Coratomic L-10 X N003056A 12-05-74 11-2(-71 Cordis 2mm X N003057A 12-31-74 12-31-74 Coratcmic L-10 X N003058A 02-03-75 07-03-74 Cordiis X N003059A 02-07-75 04-02-70 Cordis 2n X N006062B 04-13-75 0'-13-75 Coratemic L-10 X N004064A 01-03-75 01-08-75 Coratemic L-30 X >5078A 03-18-75 12-20-72 Unknown ". 091A 02-19-75 02-19-75 Coratomic L-20 X N001093A 02-05-75 02-05-75 Coratcaic L-20 X N005095A 02-10-75 12-18-68 Cordis N003096B 05-16-75 08-26-71 Ccrdis 2mm X N008098A 03-03-75 02-05-75 Medtronic 6917 X N008100A 03-24-75 Unknown Medtronic N0ll101A 03-04-75 01-30-73 Medtronic X N007103B '08-12-75 11-03-71 Cordis ). N014105B 03-27-75 03-27-75 Coratomeic L-10 X N008106B 05-16-75 Unknown Medtronic 6917 X N007109B 04-14-75 07-15-71 Cordis 2m X 9'7.110B 04-26-75 04-26-75 Medtronic X N00llllB 04-25-75 04-25-75 Medtronic 6917 X i l N00lll3B C4-28-75 01-03-75 i Medtronic X l 29 .i i ).

TTulLE 3 ITDtI7ATTCU CF ITGD PUCO.T C-100 PIC:7GIRS az c: uu; a am o.i.? u-in NU;CER PIC'I' LMD LEAD C"LCTEIC': C:CCC.Ib l !GI7db C.DI.G-i :'YCG ~. ;. (CCCED) D'PU2 7 P U C ~f.T !.W.*I r, :CE",) i D D.L i 0171 DDJL D*?C C. C-100 PictrJ ERS D: StT[EF7.C'ICRY SE.WICI N012114B 04-29-75 04-29-75 Medtronic 6917 X N00lll73 05-07-75 05-07-75 Coratomic L-10 X \\ N013118B 03-07-75 05-O'-75 !bdtrenic 6917 X N00lll9B 07-21-75 07-21-75 Coratcmic L-10 X N00ll20B 07-03-75 07-03-75 Coratemic L-1D X N020122B 06-05-75 06-05-75 Medtronic 6917 X N00312 .2 07-11-75 12-03-65 Cordis X N 5128B 07-07-75 C5-23-73 Cordis X N 5129B 09-04-75 09-04-75 Medtronic 6917 X N005130B 10-23-75 03 -2G-73 Medtronic 6917 X N009133B 07-02-75 03-73 Medtronic )' \\ u N009134B 07-03-75 07-03-75 Coratomic L-1 ) X N00ll35B 07-25-75 07-25-75 Cordis 3 ! X N00ll36B 07-10-75 07-73 Medtronic 6901 X l N017137B 09-15-75 1972 Medtronic 6901 X N00ll38B 08-07-75 08-07-75 Coratcaic X N00ll39B C8-22-75 05-10-73 Medtronic 6901 X N020142B 07-23-75 07-23-75 Medtronic 6917 X N021144B 08-06-75 03-06-75 Medtronic 6913 X N022145B 08-07-75 03-07-75 Coratomic L-1C X N ll46B 08-22-75 08-22-75 Coratomic L-10 X ll47B 09-10-75 1967 Cordis X l N023150B 03-27-75 03-27-75 Coratomic L-10 X l N0121528 07-10-75 Unknown Medtronic f 7 l 30

,y

L'\\BI2 3 ITUEZ?CICC CF II,TD PUCCZ,7 C-100 PtG7JIPG LYa2 CF GuE CE L...

i CLi. -t

..; g y 2

cent PTCm IJ7a I2 7,D t c r m: e :

2::xy?.n-l :rx;Ji-lI C :cc a-l'. iccia-c. (COJiD) B"PU."' PUCE.7 (:"U T. r, ? CD:1) CI;1 l DUI D3.L L~;C C_'_ C-100 PACD7ez.m n: S;cIsacCF1 SLT/ ICE N001156B 09-11-75 1973 Co rdis X N001157B 09-17-75 09-17-75 Coratomic L-10 X N024159B 09-05-75 07-74 Cordi s X N0221603 09-10-75 Unknwn Cordis X N001161B 09-22-75 01-05-76 Coratomic L-RO X NO20162B 09-14-75 09-14-75 P.edtronic 6917 X t 1166B 01-29-76 01-29-76 Coratomic X i r 3168B 10-07-75 09-20-70 Cordis 4ran X e a003169B 10-06-75 01-03-73 Cordis X N004170B 09-27-75 10 7 5 Coratomic L-30 X e 8 0 f e i e ). i r o I e 1 31 j y,

';1 'CJ:

ITU071'I T. C: I fl.D P! X.'. T.2 TT r ;;l pi:' - yy; int CF u i a; U.

{__ .... -- - -~~ r. d* ._,.L a -?,,,,.,,' g;tIEER PI!Z: L' AD 1 I T.'d.' ., ~ 'T!"!I T. l E7': G. l'- Mi:Cidb 1"!.1X'16-I '.lO'A'- ! (CCO:CD) DT'12;T Pli C '3 'r l '_t'OT f M !:'.) .. _ _' 'y;,_ DIli?,

DEI, "Cl-i C_7{!)

T C-100 PIC M'JEYi No LONGEn I:7 FERVICE f!001032A 11-04-74 03-03-72 Cordis X N001034A 10-11-74 10-11-74 Coratomic L-20 i X 1 f!001039A 12-13-74 12-13-74 Coratomic L-20 X N003048A 11-07-74 Unknown Cordis 2mm X N002052A 12-06-74 08-27-71 Cordis 62 cm/4mm X N002053A 03-14-75 03-14-75 Coratomic L-10 X { t N003054A 12-02-74 01-10-72 Cordis X N0010928 04-21-75 Unknown Cordis X N004097A 02-19-75 Unknown Medtronic l X N0v.,J99A 03-10-75 01-20-75 Medtronic 6917 X N005102B 36-10-75 06-10-75 Medtronic 6917 X N002108B 07-10-75 07-10-75 Coratomic L-10 X N00ll218 05-14-75 05-14-75 Coratomic L-10 X N021143B 07-30-75 07-30-75 Medtronic 6913 X i N0211498 08-21-75 08-21-75 Medtronic 6913 X N001163B 09-23-75 09-23-75 Coratomic L-10 X N0041678 09-25-75 Unknown Cordis X w I l l 32

11 T/diLC 4 ITi2LITJsTIO:1 CP Ira PIJCCC::.T. C-101 PLC52itJTPS Esic c? lvar CE i __.....u..La GGs a; u a !" Afit PT4'ER frtD tra ITS3!i?!C! !~;IYt'J.Is-KKCJ e-12.IYX M - .G /a'l- ! -- (cco m) n P L12.T P t/.c n n.T nm: r. :r.na.) nw. mcc. n:1.J. r-F - C-101 PICD*leCIT, c' FJi ! FTCCRY Sric/ICC IN001001 09-29-75 1966 Cordis X l 1N002002 10-17-75 07-29-75 Medtronic 6907 ' X 1N015003 08-21-76 05-71s Cordis X i l 1N021004 12-10-75 07-30-75 Medtronic 6913 X 1N002005 01-21-76 02-10-76 Coratcmic L-20 X 1N001006 10-13-75 10-07-75 Madtronic 6961 X 1N027007 10-23-75 05-11-73 ESB Medcor ) 1N001008 06-09-76 06-09-76 Medtronic ) ao21010 09-10-75 08-21-75 Medtronic 6913 X ,( s26011 10-02-75 10-06-75 Coratomic L-20 X j 1N001012 09-29-75 1973 Medtronic X 1NO35013 01-05-76lD1-05-76 Coratomic L-20 X l l I IN029015 11-05-76 Unknown Medtronic 5816 X f i 1N003018 03-20-76 '08-20-76 Coratomic L-10 X i 1N003019 10-24-75!10-24-75 Cora tcmic L-10 X l 1N001022 10-10-75 1972 Medtronic l X 1N034023 01-20-76 1969 Medtronic X 1N031024 10-24-75 09-15-69 Cordi s i X 1N029025 02-23-76 07-70 Medtronic 5816 X l 1N028026 10-27-75 1970 Medtronic l X '023028 11-10-75 02-71 Cordis X 1N003029 07-06-76 Unknown %dtronic X i 1N001030 11-24-75 08-11-69 Cordis X 33

TA13LE 4 ITD4I71CICII C7150 PUCC.T C-101 PIG 17d~'RS INTL CF InrL CF ! N ll CI M i E.1-L'.a.. _ i ICT.IP. PT C P. Ird) LCAD DCS:3T. TION I:.Tu'.;i-l:Jo'1Jt-1 7E J<- l

KCiG-I :.

(CCOE'D) I T LM.'r P U C E.T (WP & ?C:i :.1 I D T1J. DT;J. D!% I Pr.M. h-C-101 PIC'/FEIG D: STcIsr7C" Crc' SDUICE I INO27031 01-31-76 01-31-75 Cora tomic L-10 X l 1N028032 11-03-75 11-03-75 Medtronic 6907 X 1NO37033 11-10-75 Unknom Medtroni c X i 1N046034 05-01-76 05-01-76 Cordis X 1N002035 01-09-76 01-10-76 Coratomic L-10 X 1N002036 12-16-75 02-16-72 Cordis 62cm/4h.m X IN002037 11-25-75 12-12-75 Coratomic L-10 X 1N031039 11-07-75 09-25-72 Corids 2=a X 1 ( 4007040 11-10-75 11-10-75 Coratamic X l .5041 07-30-76 07-30-76 l Medcor P56/MTF2 i X (' i 1N007042 12-03-75 1973 l',edtroni c X 1NO38043 02-03-76 02-03-76 Medtronic 6917 X 1N053044 06-01 76 Unknoan Medtronic y 1N001045 12-04-75 12-04-75 Coratcmic L-20 X 1N032046 12-05-75 12-05-75 Coratomic L-20 X I IN007047 01-13-76 1971 Cordis X l 1NO30048 04-07-76 04-07-76 Medtronic 6907 IN001049 01-21-76 10-29-73 Medtronic 6901 i X 1N075050 09-03-76 09-03-76 Cordis X. I IN014051 12-09-75 12-09-75 .Madtronic 6901 X i 1r'34052 12-15-75 01-08-76 Medtronic 6917 X 'O'1053 02-07-76 02-06-76 Caratomic L-30 .X 1N054054 05-24-76 05-24-76 Coratomic L-10 X 1NO36055 01-20-76 01-20-76 Coratomic L-10 X I 34 I l g

TIJ1LE 4 ITD1I?.liTICIJ CP LMD PUCCC-C-101 Pt.CDMI. IS tmz 0F Iwm or ar m.u iu< i _ a : -mm__ _.._ ! -- i ICTER PT C l IJAD ID.D CITCCITIMI II:!Y I*Ts k- ! TiOCtJ 4-- f2.TXC/dt- !ECC/.F.- (ctrco) I.vucrr PUan:r 0703: s mntu.)

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n :1 '. - C-101 Plc: vel:FS D: 716TI5F7C CRY SElfACC 1N001056 03-12-76 03 12-76 Medtronic X 1N027057 02-17-76 02-17-76 Coratcmic L-10 X 1N023058 12-22-75 10-74 Cordis 2 1N018059 12-23-75 03-20-73 Cordis X 1N050060 05-14-76 05-14-76 Cora tcaic L-20 X 1N049061 04-13-76 04-13-76 Coratcmic L-10 X 1N061063 07-16-76 07-16-76 Coratomic L-10 X 1N023064 01-23-76 03-75 Cordis Bal,1. X N003065 12-29-75 Unknown Medtronic 6907! X i l g 030066 02-13-76 02-13-76 Coratcmic L-20 X 1N001068 08-13-75 08-13-76 Medtronic 6907-X 59 1N007069 04-14-76 04-14-76 Coratemic L-10 X 1N038070 01-23-76 01-23-76 Medtronic $917 X lf1041071 06-13-76 Unknown Unknown x lN027.073 02-05-76 Unknown Medtronic X 1N044074 03-10-76 09-22-70 Med tronic X 1N002075 03-09-76 05-07-73 Cordis 2m X l 1N002076 06-21-76 09-26-76 Cordis X 1N001077 01-30-76 01-30-76 Coratomic L-20 X 1N024078 01-30-76 07-74 Cordis X ,'.001079 02-23-76 07-14-76 Medtronic 6907 X t 1.,072080 10-28-76 07-22-76 Unkncwn X i 1N009081 02-05-76 Unknown Medtronic X (Screw-in) 35 t

TAllLE 4 ITD1I?ATIQi CF IIAD PIIC CC C-101 PIC:4A! IRS Lan; CF Lum cr Gau.'QI,SP IIJO CI'L"'1IPTILN ll !In n'.A!:- i:1-i s i .WE.R PA~Eit LI'?O KK.Cidt-12.UIN1-I.'T.U3d- ! I - (cccEr3) nyt; ? P!/ct;n.T ( m r r 6 t r r.: : a Dire. nitc. n:AL I n c.:. 4 ;_ C-101 PIC;WcrG IN SATISFbCTU Str /ICC 1N047082 10-07-76 07-07-76 Cordis 322-462 X 1NO38084 02-03-76 02-03-76 Medtronic X di 1N027086 02-12-76 02-12-76 coratomic L-10 X 34 IN095087 09-15-76 11-01-72 !!cdtronic X 1N023088 03-30-76 03-30-76 Caratemic L-10 X l 1N004089 : 06-28-76 06-28-76 Cordi s3P.2-620 X 1NO30090 03-02-76 03-02-76 Coratcaic L-la X l 4001091 01-05-77 Unknoten l M2dtrenic X 5 . 3092 03-26-76 03-25-76 Coratcmic L-10 X 1N040093 03-04-76 03-04-76 Caratomic L-20 X 10039095 02-13-76 ha!:ncun lbdtronic X ~ 1N095098 CD-14-76 09-14-76 Coratomic L-10 X r 1N034099 05-25-76 OG-74 Cordis X j 1N041100 02-17-76 feb. !!cdtronic 5815 X 1N047102 03-25-76 Unknown lbdtronic X 1N046103 04-09-76 06-27-73 Cordis 322-261 X 1N048104 04-16-76 04-16-76 Medtronic 6917 X IN008103 11-03-76 07-75 Medtronic 6917 i X 1N089106 02-10-77 02-10-77 ftdtronic 6917 X lN056108 04-14-76 04-14-76 Cora tomic L-10 X i N145110 12-15-77 12-15-77 Coratomic L-2 ) X "'9111 03-27-76 08-27-76 Coratomic L-30 X 1N004112 09-03-76 09-03-76 Cordis 51cm X l 1N030113 ~ 06-07-76, 06-07-76 Cordis 322-256 X l g 36 l_

TAHIJ 4 ITDtI"ATICN CT 15\\D P!1CCCT ( C-101 PACrtlJITS CYn: OF LaYn; C1' t.': l fC. I.;> q M -i u 2 l.C'nEn P73 ID,D f.D.D Cn~CmTim II.TICR-l ECCJ1-C.711/Ji-l CCC.-lI:J (CCCCD) U ?!/2.7 P!1CO Mt.' C '/J'"

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I '*?!. i '?; C-101 PICD'/JCRS D: S7CISP7CM SD*/ICC 9 IN001114 03-24-76 03 76 Coratomic L-20 X 1N042115 03-18-76 12-13-73 M2dtronic 6913 X 1N009116 05-21-76 1972 Cordis X i 1N00lll7 00-07-76 06-28-74 Medtronic X 1N001118 04-29-76 04-29-76 Unknown 1N047119 11-04-76 11-04-76 1 Cordis 322-4'62 X 1N040121 03-23-76 03-23-76 Coratomic L-10 X 1N023122 03-29-76 12-74 l Cordis l ',,042123 03-26-76 03-26-76 ; Coratemic L-10 X ( ..f7124 04-07-76 Unknown Cordis X l 1N072125 07-29-76 07-08-74 Cordis l 1N05212Cl 05-20-76 05-20-76 Coratcmic L-10 X IN045129 04-03-76' 04-03-76 Coratomic L-10 X I IN001130 C6-11-76, 06-11-76 Coratomic L-10 X 1N025132 09-23-76 Unknown ESB PS6-MTF-2l X IN00ll31 06-25-70 06-25-76 Co ra tov.ic il-20' X 322-256lI 1N 030133, 03-28-77 l 09-10-76 04-12-77 Cordis X 1N002134 Coratomic L-20 X 09-10-76 1N026135 06-11-76 06-11-76 Caratomic L-101 X 1N061137 12-13-76 09-30-74 Cordis 322-62C X i '"072138 07-26-76 09-72 Cordis X l l k 2139 11-12-76 Unknown Medtronic 6907 X l ~ 06-27-7:j 1N023140 Unknown Cordis 2m X l l

IN057141, 05-27-76 05-27-76 l Coratomic L-:X]

X I 37

'ITJ.!LL 4 ITDtIZATICI: CP LW PUC"l2.T C-101 PICl4tdrG CYC CF LGEC2 L? ' U.0L.W old.T

s

!TJ2ER PA Q LW UAD CCCCRIP*IC'1 12:Tr cle- !r/CCtdt-C."T. CAR j MYCCle.- l..-~ (CCCCD) D O I R.'T P f1C *' ? TO W.V3: A Kg.!2.) D T?d, DTM. D r./J., I r.!A*, '.~11., C-101 P/C'/ Jar; c: STCISFIC CRY SEWICC IN073142 09-28-76 1974 Madtronic X 1N008143 10-25-76 10-25-76 Cordis X 1N046144 05-21-76 01-08-74 Cordis 322-620 X 1NO30145 01-14-77 01-14-77 Medtrenic 6907-X 58 1N051146 05-20-76 Unkncun Medtronic X 1N048147 09-10-76 09-10-76 Cordis 322-462 X 1N00714 8 05-19-76 05-19-76 Coratomic L-10 X .34149 05-14-76 05-14-76 Coratomic L-10 X 1 31150 07-15-76 07-15-76 Cora tomic L-10 X t 1N012151 03-04-76 03-04-76 Madtronic 6917 X 1N055152 06-04-76 06-04-76 l'adtronic 5917 X 1N041153 06-23-76 06-23-76 Coratemic L-30 X 1N062155 09-27-76 11-14-73 Cordis 305-305 X l 1N097156 11-15-76 11-15-76 Coratomic L-10 X f lN089157 03-25-76 ~ 09-01-76 Coratomic L-10 X 1N047158 10-08-76 10-08-76 Cordis 322-462 X 1NO30159 11-01-76 11-01-76 Cordis 322-256 X i 1N00ll60 07-08-76 10-23-74 Medtronic 6919 X 1N003161 07-07-76 07-07-76 B iotronick X 1N056163 03-06-76 08-06-76 Cora+wnic L-10 X y NO30164 11-18-76 11-18-76 Co rdis 1 6 IN00ll65 08-05-76 08-05-76 Pedtronic 6907 X 8 i 1N055166 07-21-76 07-21-76 Mectronic 6901 X l 38 s

TA13!I 4 ITD4IZtiTICt: CC END PUCRCC C-101 Pl.CD'JCIPS EATE CF . b OE CF _ __....I.'JU.G A' t e;-ir.u.2.__ Inst PR~ER IM) ITAD CimCPTIC:4 !! T tY.w-

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P!?i iJ ' C-101 P/cnWCrc rr Et,TIsrtcm startCC 1N004167 08-30-76 Unknown Medtronic ) 1N077169 07-22-76 Unknown Cordis X 1N041170 09-29-76 09-29-76 Coratomic L-30 X lt:002171 09-20-76 09-20-76 Coratcmic L-10 X 1N059173 10-17-76 11-19-76 Cordis 4r,m X 1N048174 11-17-76 1973 Cordis ) 1N095175 02-03-77 02-03-77 Coratcmic L-10 X lf!003176 11-01-77 11-01-77 Medtronic 6951-58 X 1N056177 C9-25-76 03-25-76 Coratcaic L-10 X ..r '6178 12-03-76 Unknown Cordis 3 i i l 1N045180 09-23-76 Unknm.n !!ot Indicated l l 117055182 12-14-76 12-14-76 Medt. 6917-53 X 1N014183 01 07-77 01-07-77 Medt. 6037-35 X 1N059184 10-19-76 Unknown Cordis X 1N021185 76 12-01-76 Teletronic P4-X 3835 1N089186 12-08-76 12-23-74 Cordis EPI X 1N096187 02-03-77 02-03-77 Coratemic L-301 X 1N072189 02-19-77 03-05-76 Coratcm.ic L-10 X IN099190 12-21-76 12-21-76 Coratemic L-10 X l' 55191 02-11-77 02-11-77 Medtronic 6917-X 53 l t 1N060192 01-05-77 1972 Biotronik X 1N057193 12-27-75 12-27-76 Co ra tomic L-10 X IN007194 12-15-76l12-15-76 Cera tomic L-10 X 39. n

)I TIJtU: / I'IDLIZTsTICIS CF : ' PLI C TJ."' C-101 P/.1_ EPS CATc GF Ucc c? t.?q l.0Lis a R. -i ' m _ i f.U!BER PI C 1 IJJO !ITO CL"'C:'.IP~ICN !!.:Y C ! - l lGT1Jt-- .:.: r c Js-l :.:yccd-i ' (CCCCD) T'" LIMP P! /C: 71".*r uma: r, it"rM nn-t : r. c, n:rd, i "c. I. ' - C-101 PYD'IEPS I'; %TIIITTC:CTU' SEFCC" 1N101195 01-28-77 01-?.S-77 Ceratomic L 10 X 1N060196 12-29-76 09-75 Medtronic 5818 X 1N113197 02-03-77 08-74 Me.dtronic X 1!i029198 06-03-77 Unkn in Unt;ncwn / 1N062199 01-17-77 04-04-75 Medtronic 6917- .X 53 1N052200 01-11-77 01-11-77 Caratonic L-10 X 1N005201 02-04-77 10-15 74 Cordis X 1N041204 03-07-77 03-07-77 Madtronic 5815 X .60206 04-04-77 04-04-77 Biotronik X 1. 61207 04-04-77 09-10-74 Medtronic 6917 .X ( 141208 nt 04-05-77 04-06-77 Coratomic L-10 X 1N002209 04-04-77 04-04-77 Unknown X IN002210 06-29-77 1974 Medtronic 5945 X j i 1N003211 03-24-77 03-24-77 Coratomic L--10 X l 1N030212 O 10-05-10-77 Coratomic L-10 x i 0p 18 77 1M097213 // 04-15-77 Coratemic L-10 X j if'001214 10-17-77 Unknown Co. dis X 1N002215 04-28-77 04-23-77 Coratomic L-10 X i 1N142216 04-27-77 04-27-77 Coratomic L-10 X l IN041218 04-27-77 Unkncun Medtronic 5318 X 1N059219 04-29-77 04-29-77 Coratcmic L-10 X-1N020220 06-13-77 06-13-77 Ceratomic L-10 X IN075221 05-19-77 05-19-77 Coratomic L-10 X . 07222 05-24-77 05-01-75 Medtronic 5815 X I ( m055223 05-12-77 Unknown Medtronic X i IN003224 07-21-77 10-21-76 ,1 Cordis X l IN002225 09-22-77 09-22-77 Cordis 2mm/62cm [ X I 40 I s

'I7d LII 4 ITD112ATICU OI' II'/d) PIICl?CLT C-101 PICD*/dCRS ". RIAL IL'1E OF iJ/GE OF UN D'01/G Dl-1-N Ao ..Jt 211'R PICER IHJ) 11'Jd) DISCRIPTItt! D;i7X'AR-fMX.AP-DiDCCAR-MiDd).- 1 (CODID) 11"21RTT PIlfl7I!2TT (? *.'03; f !!E:1)

DITJ, DIld,

DIld, DIlsL. (Gr!.R C-101 Plc7nl:nis III mTIsr/C'ICRY SCIUICE lill42226 06-20-77 06-20-77 Coratomic L-10 X

IN101227 07-22-77 07-22-77 Medtronic 6917 X liiOO1229 06-15-77 06-15-77 Coratomic L-10 X if!029231 06-13-77 04-14-77 Medtronic 5818 X IfiOl7232 06-09-77 05-09-77 Medtronic 6917/53 X if4001233 09-23-77 09-23-77 Medtronic 6917/5: X if1046235 06-20-77 06-20-77 Cordis 322-620 X lfiO29236 09-12-77 09-12-77 Coratomic L-30 X 1" '236 09-12-77 09-12-77 Medtronic 6917; X lf.. J237 08-19-77 05-14-77 Cordis 322-256 X 1riO30238 08-29-77 Unknown Unknown X IN002240 12-14-77 i 12-14-77 Cordis 62 cm/2mm X lil046241 07-25-77 10-22-75 Cordis 322-620 X liiO20242 07-26-77 07-26-77 Madtronic 6917 X 1ri101243 09-12-77 09-12-77 Medtronic 6904 X IN046244 07-11-77 Unknown Cordis 322-620 X 1N098245 09-13-77 09-13-77 Cordis 322-462 X IN143246 07-12-77 07-12-77 Medtronic 6901-58 X IN001248 01-03-78 01-03-78 CoratomicL-20 X IN052249 01-11-78 01-11-78 Coratomic L-20 X 1 IN046250 11-25-77 11 _5-77 Coratomic L-10 X {"',251 08-10-77 Unknown Coratomic L-10 X 1 Nil 3253 08-11-77 08-11-77 Coratomic L-30 X t INil3255 09 '6-77 09-16-77 Coratomic L-30 X IN101256 09-20-77 09-20-77 CPI 4110 X

Uu1LE 4 ITIRIZ7sTIQ2 OF ILV) PI1CIM27T C-] 01 PN?l1W'J lti SEPJisL ifd"G OP i&'G1; UF l.,NIPOl/f if1-loild) !.UCER PTCP. IJ7.D LETJ) CPSCRIPTIGJ D? m R- . WOC 7Ji-D7JOCAR- .WOCTR-(CTCD) IMPIR7T PI F ITJ:TT I (NT & f DDEL) DIAL DIE DIAL DITE CrnE C-101 PNTW3:IE DI StaIsrtcIORY SEINICE IN029257 09-14-77 09-14-77 Medtronic 6917/30 X Coratomic L-30 X 1N002258 . 11-17-77 11-17-77 Cordis 62cm/2mm X 1N029259 02-21-78 02-21-78 Medtronic 6917/5: X 1N002260 10-14-77 10-14-77 Cordis 62cm/2mm X 1N101261 10-03-77 10-03-77 CPI 4110 X 1N002263 10-11-77 10-11-77 Cordis 62cm/2mm X l 1N006264 03,21-78 12-11-73 lMedtronic6907-5E X 1N008265 02-23-78 02-23-78. Medtronic 6917/35A X 1m 41266 10-12-77 10-12-77 Caratomic L-10 X 1N097267 10-18-77 19-18-77 Coratomic L-10 X l 1N002268 12-05-77!11-30-77 Medtronic 6917 X 1N002269 11-15-77 l11-24-77 Cordis 62cm/2mm X i 1N146270 01-26-78 01-26-78 Coratomic L-10 X IN002272 11-18-77 11-18-77 Cordis 62cm/2mm X 1N001273 02-27-78 02-27-78 Medtronic 6907-5E X y 1N144277 12-03-77 12-03-77 Medtronic 6917/3E X 1N036278 11-18-77 12-14-74 Medtronic i X 1N003279 12-05-77 12-05-77 Cordis DC0 X I 1N036281 12-05-77 04-23-75 Medtronic 6907 X l 1N147283 03-24-78 03-24-78 Coratomic L-10 X l59284 12-14-77 12-14-77 Cordis 322-462 X l [ 1N015285 12-08-77 12-08-77 Coratomic L-10 X i 1N147287 04-10-78 04-10-78 Coratomic L-40 X 42

ME 4 ITU41ZTsTIO1 OF II/O PIICIMNT C-101 PAC 17'N3:1:; SIRIlsL Iyat OF 1Wil; OF tHLl'UI/\\11 ljl-112UW ni m mt P7 art IJnD u70 DImtIPTIor; 12nt r x t-mocm-c:Docm<- m ocrat-(GUI2)) I?;'! /iTT PI/Ci U?f" (Al3: 1. f DDU,)

DIld, DIM,

DIIJ, DIld, OIlli C-101 p.C';tEnly; III.%TI ;P7CIDW SElWICE lil046290 06-08-78 06-08-78 Cordis 322-610 X

If1037291 02-20-78 02-20-78 Medtronic 6917/53A X lil007293 04-03-78 04-03-78 Cordis 2m tip X liiOO2295 02-21-78 02-21-78 Cordis 62cm/2mm X Ifil47298 06-30-78 06-30-78 lCoratomicL-40 X lil146302 02-21-78 02-21-78 Coratomic L-10 X 1N029305 08-17-78 08-17-78 Coratomic L-10 X l 1N023306 02*24-78 02-24-78 ' Medtronic 6917/35 X l l I 43

'IAllII 4 .'11MIA"'IOJ OF IEAD PI1CIM271' t.*--101 l'7Cl2%KElti SIRIAL LWIE OF iVM: Ol' l LTHRil AR BI-POIM fr21ER P703t ITAD j IFAD DITCIIPTIOJ 17.'DnCTtil- ! MICX' Alt-C.'DOCldt-F"zDCAR-(CODED) IMPIN TI' PL N " 37;I,j (WsKE & IIr>II) DIt1 l DIt1 DIAL DIIL UITE C-101 IwT1AKas III SATISPICICIrl SElWICE IN146307 07-06-78 07-06-78 Coratomic L-10 X 1N017308 02-13-78 02-13-78 Medtronic 6917-f 3 X 1N147310 03-07-78 03-07-78 Coratomic L-10 X 1N147311 05-30-78 05-30-78 Coratomic L-40 X 1N147312 03-22-78 03-22-78 Coratomic L-10 X 1N146313 07-03-78 07-03-78 Coratomic L-40 X 1N145314 06-27-78 06-27-78 : Coratomic L-10 X l 1N147317 08-09-78 08-09-78 ! Coratomic L-40 X "'147318 08-27-78 08-22-78 Coratomic L-40 X 1N147319 03-28-78 03-28-78 Coratomic L-10 X 1N147321 03-22-78 03-22-78 i Coratomic L-30 X l l 1N015324 05-26-78' 1974 Ccrdis X i 1N147327 07-03-78' 07-03-78 Coratomic L-40 X l 1N146328 07-06-78 07-06-78 I Corstomic L-40 X 1N0091001 02-22-78 02-22-78 Coratomic L-10 X 1N1471002 08-17-78l08-17-78 Coratomic L-40 X 1N1471003 07-11-78 07-11-78 Coratomic L-40 X i l l I l

TA!!!I 4 '" M!"1"1CtJ OF IIAD PI,'CIM,73 (?-l01 l'tCl71AFJ:1L 3DTD1 tyat UF I W P., ( ' 4 (;N il'O A R i ijl--i= H Au l ! LFJO CI'iX3tIPTIOt1 ra m IUt P/GR IT/J.' 1H't X'1d t-MYOCrJt-F2;DOCAIR- !&Ji' di-l (Cor42)) IMPI,t r I'l h ' MI; ;." I (fMKr. & MXI2,) DIAL DIAL CIAL DIli IC71'- C-101 PACEMAKERS NO LONGER IN SERVICE 1N001014 10-24-75 10-28-75 Coratomic L-20 X 1N001020 01-23-76 01-23-76 Coratomic L-20 X 1N012021 09-04-75 Unknown . Medtronic 6913 Y l 1N029027 10-25-75 10-25-75

Medtronic 6917 X

1N033038 12-14-75 08-09-73 ESB Medcor P56 X 1NO30062 02-13-76 02-13-76 Coratomic L-20 X 1N023067 02-11-76 01-21-73 Cora tomic 'L-10 X 1N07?096' 08'05-76 08-05-76 Coratomic L-10 X 1N023109 05-02-76 Unknown Medcor P56-2 j X g i i i IN001120 04-06-76l04-05-76 Coratomic L-20 X 1N072127 05-21-76 05-74 Cordis X l 1NO30133 03-21-76 04-13-76 Medtronic 6907 X 1N100136 01-08-77 01-08-77 Medtronic 5951 X i i 1N004172 10-01-76 10- 05-73 Medtronic 6901 X 1N001072 03-18-76 03-18-76 Coratomic L-20 X i i 1N023085 02-12-76I02-12-76 Coratomic L-10 X 1NO30126 10-21-76 ;10-21-76 i Cordis 2 m X 1 I 1N098179 10-02-76 '12-23-76 ! Cordis X I 1N030181 11-03-76 Unknown Medtronic X 1N002292 01-30-78l01-30-78 Cordis 62cm/2m X l 1N100297 03-10-78 03-10-78 Medtronic 6907 X l, I i j l I i I l 45 i i

TABLE 5 ITEl41ZATI0tl CF IDEllTIFICATI0ft AtlD C0iiTACT BElflG lGILED C-100 PACEliAKERS u fl0TIFICATION tt0TIFICATI0tl RECEIVED RECEIVED SERIAL DATE OF MOST BRACCLET AilD II:D' CATI;iG I:lDICAT!!;G ErFE T: lJul!3ER RECE:li FOLLO.!-UP PERMNIE;li I.D. PATIE!!T CARRYIfiG PATIEllT WEARitiG C C.'! TAC (CODED) EX/f t!! AT10:1 CARD MA! LED? I. D. CARD? SRACEL ET? "AI::'A '. N001027 03-28-78 yne yq.S Yes Yes-N,0_01028 01-0G-76 Yes Yes Yes Mc? N001029 05-l'i-7R Yes Yes Yes Ye s_._ _N002030 Ofi-14-78 Yes Yes Yes Yes __ N00,2031 01-29-7_6 Yes Yes Yes Na2 _ N002033 03-22-78 Yes Yes Yes Yes N00,2_035 07-14-77 Yes Yes Yes No2 N002036 11-16-77 Yes Yes Yes t!o3 N002038 04-12-78 yne yne vne Yes,._ ( N003040 07-07-78 ve en eu n

n.,

2 N006_041 09.A9 77 Yne _i-Yer YM S9-N001042 06-06-78 vns vne ve v n n. __ N002043 05-17-78 yes yot va, Yes N002044 08-16-78 Yes he Ya* V"" 1:002045 11-19-75 yns yn yne flo2,_ flo3 N00,2046 10-26-17 ye yo, v33 N001_047 03-07-78 Yes vne _yes _ ver N002049 05-17-78 yes yes_ yn, Yes .__ _N001050 08-01-78 Yes Yes yo, y _N_0,0 3 0 51 05-09-78 yes , jgo_, n, Yc,__ \\ 46 r

TABLE 5 ITEMIZATIO 10F !DElli[FICATIO 1 ArtD C0rlTACT BEItlG t%ILED C-100 PACEf TAKERS 1 !10TIFICATIO1 !!OTIFICATIO!l RECEIVED RECEIVED SERIAL DATE OF l0ST BRACELET AliD lt:D ICA,Tli;G IfiDICATlllG EFFECTD IU."SER RECE!:T FOLLCl-UP PERMAtlENT I.D. PATIEtlT CARRYII;G PATIE!!T WEAR!:lG CC::T 'iCi (C0CED) EXA!!!!!ATIO:I l CARD MAILED? I. D. CARD? G RACEL ET? "A U l l.. '. ; l N003055 07 07-78 Yee fin No VS N003056 04.26-78 Yes No ' "-~ ~FT0 0 3 0 5 7- - 06 ns yes_ un-~ fl0 YOS '.',-----"~V" N003058 07-07-78 yes t'0_ "o vL r N003059 0@-02-78 yns no no D. __ N006_062 _04-19-78 yee yps yo, _Yes.__ N004064 n? 11 76 vn-vge ve "C_. n N005078 04-13-78 yne n, n, Yes N001091 05-16-78 Yes v., e ven v ne t N00J093 03-28-78 yn, No Yes yn N005095 07-28-77 vy,, ' ig Yos U02 N005096 06-02-78 yn, ,,n nn y t.t N00809_8 11-05-76 yn, vn yot

ep N008100 01-20d6 vos Yes Ynt Mal __

N011101 0 3 -04_- 75 _ __. ___ __.__ Yes _. __ __.Ib.. t'n Me __ NOA22y 02-14-77 No2 vg yg v,n N 014,1,0.5 _32.y,_J7 vne , __ _ _ yen _, M v,e N008106 09-16-77 __ _ yet .yg n vnt No3 N007109 04-15-77 yn; yne yn, No2 ._ __t1012110 _01-05-78 yc : vne yne No3 N001111 06-13-78 yos ,yp e yo, v3_ N001113 04-10-78 yos yes voy Yes 47 b

TABLE 5 ITEMIZAT10!i 0F IDENTIFICATION Aft 0 C0t1 TACT SEI!iG l' AILED C-100 PACEMAKERS fl0TIFICATIC:4 fiOTIFICATI0ff RECEIVED RECEIVED SERIAL DATE OF MOST GRACELET AfiD If;DICATIi;G ItDICATII:G EFFECT*'. NUMBER RECE;iT FOLLCl-UP lPEFMtENT I.D. PATIEllT 'CARRYIllG PATIEtti UEARIllG C0:17ACT (CODED) EX AMIt!ATIO:t i CARD MAILED? I. D. CARD? B P.ACELET? t'AI:O :"" Mn12114 12-06-77 Yoe Yo<,_, yg, No3 nnn1117 06-27-78 Yes Yes Yes Ye n tLQ131]8 02-16-77 Yes Yes Yes . _,J!o,9 N001119 04-10-78 yes Yes No Yes N00ll20 05-22-78 Yes Yes Yes Yes _ NO20122 04-13-76 Yes Yes No No? N003126 05-30-78 yes un no yes N015128 03-15-77 Yes Yes Yes yo2 N005129 05-23-77 Yes No No' No2 N005130 04-10-78 yes No No Yoe i N009133 11-17-77 Yos Yes No No3 N009134 07-03-75 yns no No

o?

N001135 06-05-78 Y's Yes Yes veg_ e N00ll36 11-01-77 Yes Yes Yes No3_ __ N017137 07-18-78 Yes Yes IIU ,Yes _ N00ll38 07-25-78 Yes Ye_s Yes Yg _ 08-01-78 Non1179 ygy yn, ygy Yes 07-31-78 N020142 Yn Yes No vos ~ NO21144 ~ Yes Yes~ Yes Yes N022145 04-04-76 Yes Yes Yes flo? N001246 01-13-76 Yes Yes Yes "3; _ 04-17-78 N00ll47 Yes Yes Yes Yes N023150 -0 Yes Yes Yes Yes. 48 b

TABLE 5 ITEMIZAT!0tl 0F IDENTIFICATI0fl AfiD C0tiTACT BEIflG r%ILED C-100 PACEMArERS s tt0TIFICATI0ft fl0TIFICATICl1 RECEIVED RECEIVED SERIAL DATE OF 1*,0ST BRACELET AfiD INDICAT!!;G ItiDICATI:;G EFFECT :'. fiUMBER RECENT FOLLC'.1-UP PER?!.:ENT I.D. PATIEtlT CARRY! :G PATIE.'iT UEARI;;G C^.'lT X T ( CODED) EX/f!IN ATI0l; CARD : TAILED? I. D. CARD? BRACEL E 7? MA!'!T! *:f N012152 05-11-77 Vas Yes. Ye-Non1156 09-14-77 ve yns No3 vs e e Noo11 eM 02-05-76 Yne vne yns Un? N024159 99-05-75 Yes No fb M2__. NO22160 09-10-75 vn No ?!o ?;0 Z___ N00116) 07-20-76 Yes Yes Yns I!O2 N 0 2 016 ') 03-15-76 Yo e, fin Mn IIC2 N001166 06-20-78 yns yns yn e_ vny 07-07-78 N003168 Yns tb M6 vac N003169 04-27-78 yne n, nn v,, N004170 _04-14-78 yn, yo, y_, y O e e =e se h 94 46-49 w

TABLE 6 ITEMIZATIO!! 0F ICENTIFICATIGl1/J1D C0:lTACT BElfiG MAILED C-101 PACEMA!'ERS fl0TIFICAT10N fiOTIFICATI0ft RECEIVED RECEIVED SERIAL DATE OF MOST BRACELET /J10 IliDICitTIllG IllDICATIitG l EFFECT: NUM3ER RECEitT FOLLC,!-UP PERMA'!EiiT I.D. PATIE:T CARRYING PATIElli UEARINGl Cf; TAIT CC:!AC (C0DED) EXAMit!ATICN I CARD MAILED? I. D. CARO? BRACELET? i 1N001001 03-21-7A Yes Yes Yes Yes 1N002002 11-30-77 Yes Yes Yes No3 1N015003 05-16-77 Yes ib No NO2 s 1N021004 10-07-77 Ye s Yes Yes No3 I lN002005 04-19-78 Yes Yes Yes Yes 1N001006 08-15-78 Yes ~Yes Yes Ye g__ INO27007 05-15-78 Yes No No Yes IN001000 10-25-77 Yes Yes Yes Yes__ i 1N021010 03-15-78 yes Yes Yes Yes 1N0260ll 10-02-75 _Yes No tio th2 1N001012 01 -2.5-77 Yes Yet Yes NO2 INO35013 09-04-76 Yes tJo !!o !!o2 ]N029015 02-0G-78 Ye s Yes Yes Nn3 1N003018 hl9-78 Yes No !!o Yes 1N003019 05-04-78 Yes No No Yes IN001022 nc_1o_;7 Yes ve No M e INO34023 06-26-78 Yes Yes Yes Yes 1NO31024 '11-22-76 Yes No No NO2 1N029025 02-07-77 Ye s Yes Yes NO2 1N028026 03-03-76 Yes Yes nn pol _ 1N023028 08-07-78 l yes No No Ye: 50

TABLE 6 ITEMIZATION OF IDEllTIFICATIC:1 Al1D CO'lTACT BEING MAILED C-101 PACEMAKERS NOTIFICAT10ii tiOTIFICATIC,N RECE!VED P.ECEI VED SERIAL DATE OF MOST CRACELET At:D IfiOICATING !!DICATING EFFECT: NUlG EP, RECEilT FOLLGI-UP PEFJ:AliEliT I.O. PATIEliT CARRYItlG PATIE?iT UE;,RI::G C 0'i TA '. (CODED) EXAMiliATIC:: CARD MAILED? I. D. CARD? BRACELET? Ft I NT A I.*: IN003029 07-14-78 Yes No No Yes IN001030 11-14-77 Yes Yes Yes INO27031 01-04-78 Yes No Yes "O IN028032 Q3-16-76 Yes Yes Yes No? 1NO37033 10-29-76 Yes Yes Yes N02 INO46034 04-27-78 Yes ' Yt.s Yes Yes 1N002035 03-03-77 Yes Ng Yes No2 IN002036 11-OR-77 Les Yes Yes b ___ m IN002037 10 96 77 Yes Ye s Yes NO3 IN031039 06-16-77 Yes No No No2 IN007040 05-10-77 Yes _.___Ye s Yes .No2__ IN025041 07_M_7A yes gn tM Mo2 .kN007042 06-07-77 yns yes yo, No2 INO30043 05-Q2-7A yes yes yes Yes IN053044 06-02-77 yes Yes Yes No2 1N001045 _04-17-78 yes yes vae Yes IN032046 .08-21_78 voe yns yes vn, ynh Yes IN007047 05-19-78 yes yes 1NO30048 04-07-76 Yes No No No2 IN001049 06-06-78 Yes Yes Yes Yes

g

_lN075050 _Q.9_ _7j_-]6 Yes No No No2 1N014051 06-24-76 Yes Yes Yes No2 INO34052 03-29-78 Yes Yes Yes Yes 51 s, s-

TABLE 6 ITElil2AT10N OF IDErlilFICATICit AND CC:lTACT DEING t! AILED ( C-101 PACEMAKERS NOTIFICATION NOTIFICATION RECEIVED RECEIVED SERIAL DATE OF MSST 8RACELET AND INDICATING INDICATING EFFECT! 4 AMENT I.3. ! PATIElli CARRY: IlUMBER RECENT FOLLCU-L'P PER NG PATIENT 'dEARING C0 i!AC (CODED) EXAf tINATICil CAPO MAILED?f I. D. CARD? BMCELET? 9:NTA:" 1N011053 02-07-76 Yes No No llo2 IN054054 06-29-78 Yes Yes Yes Yes 1N036055 07-18-77 yes Yes Yes No2 1N001056 08-01-78 Yes Yes Yes Yes 1N027057 04-04-78 Yes Yes Yes Yes 1N028058 04-20-76 Yes Yes Yes NO2 IN018059 12-23-75 Yes No No f!o? 1N050060 06-78 Yes Yes Yes Yet i _IN049061 _04-19-76 Yes Yes No No2 1N061063 11-12-76 Yes Yes Yns NU2 lN023064 ) 05-18-77 Yes Yes Yes No2 _ IN003065 05-16-78 ye3 gn en Ycs INO30066 02-13-JG yes No No NO2 1N001068 02-27-78 yes yes ye s Yes IN007069 04-15-77 Yes Yes Yes No2 1N038070 02-01-78 Yes Yes Y e s_,_,, No3 IN041071 06-13-76 No4 No No No2 1N027073 01-18-78 Yes Yes Yee No3 IN044074 11-18-76 Yes Yes Yes NO2 lN002075 01-17-77 Yes Ye s Yes NO2 1N002076 03-08-78 Yes Ye_s Yes Yes .,( 1N001077 07-10-78 Yes Yes Yes Yes 1N024078 01-30-76 Yes No No No2 52 g,

TABLE 6 ITEMIZATION OF IDENTIFICATI0:1 Atl0 C(rtTACT BEli1G MAILE0 C-101 PACEMAKERS ( !!0TIFICATI0ti NOTIFICATI0ri RECEIVED RECEI"ED SERIAL DATE OF l'OST BRACELET AND It:DICATIriG IllDICATING EF ECT! NUP3ER RECEitT FOLLO.1-UP pen :A:!ENT I.D. g PAT!Etti CARRYING PAT!Ei!T WEAR!!;G CO::TI-C i (CODED) EX AMillATICif CARD MAILED?I I, 0.' CARO? BRACELET? N ! :;T ' ": IN001070 04-18-18 voe yn e vne Yes ]JLO M 80 10 19.76 Yot No fin Nof.., 1 N o.0.9 0 81 12-0.1-77 'ne Yo< Yoe No3 ]N047082 10 n7 7; (n e Nn >:n No 2_. __ INO38084 04-0c 76 Yne Yns Yae ?Io2 INO27086 0? 19 7A Yne Nn Pfn ?!c2_ --._J N 0 9 5 0 8 7 .05L-15-76 ... Yee .... No No. _. N o 2..- lyn n o p r-06-05-7A Yes Yes vne .,,,s l 03-]7 78 __1N 0 0 4 0 8 9 ve vne vne Y_es n 1NO30090 33.,0L7: vs N-

02 1N001091 03-07-78

,yg[ yn, yog vn, l'N023097 Q6-21-78 yes yes yu y,, e IN040093 06-16-78 ygg yn3 ygg yes 1NO39095 ,0_9-08-77 yes yes yes Nc3 lN09509E 05 31-77 Yes Yes Yes 02 INO3409$, '1C 7 7 Ype No vne NO2 IN041100

5-?a 77 ypq yog yn No2

_. l_N047102 ' ' 07-01-7_6 Yes Yes Yes No2 IN046103 07-21-78 yg; ygg yg3 ygs. _ INO48104 04-If. L6 Yes !!c No ilo2 .( _ltJ008105 11-03-76 Ye s No No No2 l IN089106 02-10-77 1 Yes No No N g2._ 53

TABLE 6 ITEMIZATION OF 10EtiTIFICATICf! t1;D CDITACT BEING MAILED C-101 PACEMAKERS ,i !!OTIFICATICH NOTIFICATION RECEIVED RECEIVED SERIAL DATE OF MOST BRACELET AttD Ill0ICATliiG IttDICATiliG EFFECTI NUMSCR RECEi!T FCLLC!.l-UP PERT-:ANENT !.D. PATIENT CARRYING PATIENT h' EARING CCM4 (CODED) EXAM!"ATIC:1 CARD IMILED? I. D.' CARD? GRACELET? l ter,i.'iT ' P-IMO59108 fP-14 7fi Yes No No Mc2 ]?!145110 12 - 15.-J 7 Yes No No f*M

u. o o u _

..c,-,o es i no no 402 IN004112 04-11-78 Yes Yes Yes Yes 1N030ll3 Ocma 7 Ye_s No Yes No2 IN00llla 05-22-78 yes yes yes Yes 1N042115 03_-29-76 ves Y,es Yes Me? 1N009116 01-19-78 Yes Yes flo No3 IN001117 11-08-77. Yes Yes Yes No3 IN00ll18 ')5-l_6-78 Yes Yes Yes Yes 1N047119 11.nJ-JJ, yes No no no2 IN040121 ll_ql_Z7 yos yes Yes No3 J.N023122 01-18-78 Yes Yes Yes

No3, IN043123 03-26-76 Yes ib No No2 INO27174 05-04-78 yes yes yes Yes 1N072125 06-06-77 Yes Yes Yes No2 IN052128_

06-23-77 Yes No Yes No2 =_ IN045129 12 02-76 Yes Yes Yes NO2 IN00ll30 06-06-78 Yes Yes Yes Yes IN00.ll31 06-27-78 yes yes yes Yes ( I N 0_P 51_3.2 09-23-76 Yes No No ffo_2 taufu na va cu-/< rea no du _ No2 IN002134 01-13-77 Yes Yes Yes No2 l IN026135 06-11-76 Yes No No l Blo2 54 ~ ~ w _

TABLE 6 6 I ITEllIZATION OF IDEllTIFICATICfl AND CONTACT BEING 11 AILED C-101 PACEMAKERS i iI~ 110TIFICATION NOTIFICATION i RECEIVED RECEIVED i SERIAL DATE OF I40ST GRACCLET AND INDICATING I!:DICATING EFFECT' !!UlGER RECEllT FOLLQl-L'Pl PLE:'ANEi;T I.D. FATIENT CARRY!NG PATIEf;T WEARII:G CC;~ ~ t (CODED) EXAMI!!ATICU CMD MA! LED? I. D. CARO? I ,_ BRA C EL ET' '0 ":! A. ' 1 IN061137 08-18-78 Yes YIs Yes Y e s.--_ 1N072138 07-26-76 Yes ?!o !!o NO2 1N052139 05-17-77 Yes No Yes No2 1N023140 03-22-78 Yes Yes Yes Yes 1N057141 10-03-77 Yes Yes Yes NO3 1N073142 09-28-76 - Yes flo No No2 1N008143 10-2546 Yes !!c tio NO2 1N046144 02-27-78 Yes Yes Yes Yes 1N030145 01-14-77 Yes No tio NO2 1N051146 05-20-76 Yes !!o No "c"' 1N048147 09-10-76 Yes No No NO2 1N007148 07-26-78 Yes Yes No Yes 1N034149 04-03-78 Yes n Yes Yes Yes m - 1N001150 06-13-78 Yes t Yes Yes Yes 1N012151 09-L5-75 Yes Yes Yes No2 IN055152 07-31-72 Yes Yes Yes YES 1N041153 09-29-76 Yes Yes Yes No2 IN062155 08-03-78 Yes Yes Yes Yes IN097156 11-15-76 Yes No No NO2 1N089157 07-01-77 Yes No Ycs No2 y 1N047158 10-08-76 Yes No No' No2 INO30159 11 01-76 Yes Yes Yes NO2 55 \\

TABLE 6 ITE!4IZATIO!! 0F IDEi;TIFICATIC:i AllD C0!! TACT BEING MAILED C-101 PACE! TAKERS fl0TIFICATIO:1 NOTIFICATIO1 RECEIVED RECEI' LED SERIAL DATE OF ttCST BRACELET AtlD IftDICATIllG IfiDICAT IliG EFFECTI NU!GER RECEitT FOLLO.1-UP PER'tA iEliT I.D. PATIE;iT CARRYING PATIEtiT !! EARING CC ~ ~ C (CCDED) EXA!!!!MTIC:! CARD 5'. AILED? !. D. CARD? BPACELET? t'A I.'F J, 9 1N00ll60 02-14-78 yes Yes yes No3 1N003161 08-26-76 Yes th tb NO2 1N056267 01-20 77 Yes Flo Yes flo2 IN 0 3,,0.154 11-19-71 Yas "o fM N O 2__,. IN00ll65 02-07,78 yng yes yyy No3 IN055166 08-01-78 yo, Yes Yes yny 3N004167 06-13-78 yg, vgy yyy Yes _ 1N077169 10-05-75 Yns fic P!n NO2 1N041170 05-03-77 y3 yes y t. s

No2_,

g _( 1N002171 08-16-78 i yg, Yes Yes y,. c lN05917_3 11-19 7s yne r1n !s !!o2 IN048174 17-g7,77 yne _yes g No3 1N095175 ,0j - 2,,c, 77 yne yo, yo, NO2 IN003176 04105-78 Yes No no res ] S 0 a o 1 Ti_ c o _ p g _7 ti-_. Yo< th fin NO2 JN05617R 17 0 4-7C van t'a ts 'N02 IN045180 12-21 7A v-Yne ve c NO2 J. -e- _lN055182 06-27-78 Yes_ Yes Yes yee _ 1M014183 02-77 Yp e. Ph th NO2 _IN059184 11-12-76_,_ Yns FM ?M No2 ( _lN021185 06-21-78 ye.- Yes Yes Yes _, IN089186 07-20-77 Yes _Yu vos Nq2_ 56 s

TABLE 6 ITEMIZATION OF IDENTIFICATICt AtiD CONTACT BEING MAILED C-101 PACEMAKERS fl0TIFICATION NOTIFICATI0ft RECEIVED RECEIVED SERIAL DATE OF MOST BRACELET AND IfiDICATII;G INDICATING EFFECTI tiUl3ER RECENT FOLLG!-UP PERMANENT I.O. PATIENT CARRYING PATIElli WEARING CC'i!,' C (CODED) EXAMl!!A TI C.'! CARD MAILED? l. D. CAF.D? GPACELET? "A I N T A '.' 1N096197 07-26-78 yn, Yes Yes Yes 1Mn??194 n?.10.77 Voe Um Yne NO2 1*1000100 I? ?l_7t" vne No N02 - 1 MO U101 09 11.77 yc3 yg y;; _,_J[02 1N060192 05-16-78 Yes Yes vy, y,, 1N05210' OR.0A-J7 No2 ve !s n, n 1U00719a 03-1.4-78 yn, vn, vg,.

Yes, IN101195 01poh7 va t Nn No Nn?

1N06039g 05-16-78 y,, ypc ye, y& 3N113197 _12 1c 77 vne No3 Y,es Ds lu G29' 198 06-14_-78 Yes Y.aJ ___ _ _ _ _ _ _ _ Yee Yes 1N052100 06-27-78 v, ygs yne yg n 1N052200 ll-la-77 Yo n Yat

S No3 1N005201 03-01-78 Yes No No Yes IN041204 03-07-77 Yes No No No2 IN060206 05-18-78 Yes Yes Yes Yes IN041007 04-04-77 Yes No No No2 IN141208 10-21-77 Yes Yes y[s No3 INO30209

'04-04-77 Yes No No No2 IN002210 12-07-77 Yes yes yes No3 IN030211 06-23-77 Yes No No No2 k_ hes I lt 1 S es es gN00_1214 0,6-06-78 Yes Yes Yes Yes "D '-W 02-22-78 Yes Yes Yps llo 57

T/SLE 6 (- ITEttIZATION OF IDENTIFICATICU NiD C0!tTACT BElilG I4 AILED C-101 PACEMAKERS tl0TIFICATIOil NOTIFICATIO:s RECEIVED RECEIVED SERIAL DATE OF MOST BRACELET N!D IIIDICATING INDICATIi4G EFFECTI'; NUfGER RECENT FOLLOM-UP PERMAi1ENT I.D. PATIENT CARRYIf1G PATIENT UEARI!!G C0i! TACT (CODED) EXAMINATION CARD MAILED? I. D. CARD? BRACELET? mal!;TAINE IN142216 04-27-77 Yes No No No2 1N041218 05-24-77 Yes No Yes No2 IN059219 04-29-77 Yes No flo No2 IN020220 05-03-78 Yes Yes Yes Yes .lN075221 05-19-77 Yes No No No2 lN107222 05-25-77 Yes No No U IN055223 09-07-77 Yes No tJo "O IN030224 07-21-77 Yes No No No2 IN002225 09-22-77 Yes No No No 3__ IN142226 06-20-77 Yes No No No2 IN101227 01-10-78 Yes Yes No No,3 1N001229 OZ-18-78 yes yes yps ym 1N029231 06-14-78 __Yes Yes Yes Yes 1N017232 04-17-78 Yes Yes Yes Yes 1N001233 08-08-78 Yes Yes Yes Yes 1N046235 07-06-78 Yes Yes Yes Yes 1N029235 n4-03-78 Yes Yes Yes Yes 1N083237 08-19-77 Yes No No No2 1N030238 08-29-77 Yes No No "2 IN002240 08-16-78 Yes Yes Yes Yes {,IN046241 10-16-77 Yes No No 1N020242 07-26-77 Yes No No 1N101243 01-09-78 Yes Yes N3 No 58

TABLE 6 ITEMIZATION Of IDENTIFICATI0fl AND CONTACT BEING MAILED C l01 PACEMAKERS fl0TIFICATION NOTIFICATION RECEIVED RECEIVED SERIAL DATE OF MOST 8RACELET AND INDICATING INDICATIi1G EFFECTIVE NUMBER RECENT FOLLOW-UP PERMANENT I.D. PATIENT CARRYING PATIENT WEARING CONTACT (C0DED) EXAMINATION CARD MAILED?

1. D. CARD?

BRACELET? MAINTAINE[ 1N046244 07-17-78 Yes Yes Yes Yes 1N098245 09-13-77 Yes No No No3 1N143246 08-01-78 Yes Yes Yes Yes 1N001248 01-03-78 Yes No No No3 1N052249 01-11-78 Yes No No No3 1N046250 08-08-78 Yes Yes Yes Yes 1N065251 08-10-77 Yes No No No2 1 Nil 3253 03-17-78 Yes Yes Yes Yes 1N113255 09-16-77 Yes No No No3 1N101256 i 01-27-78 Yes Yes No No3 1N029257 04-03-78 Yes Yes Yes Yes 1N002258 11-17-77 Yes No No Nc3 1N029259 02-21-78 Yes No No No3 1N002260 10-14-78 Yes No No No3 1N101261 02-03-78 Yes Yes No No3 1N002263 02-15-78 Yes Yes Yes No3 1N006264 04-05-78 Yes Yes Yes Yes - 1N008265 02-23-78 Yes No No No3 1N141266 04-04-78 Yes Yes Yes Yes 1N097267 05-12-78 Yes Yes Yes Yes 1N002268 01-18-78 Yes No No No3 1N002269 12-07-77 Yes No. No No3 1N146270 01-26-78 Yes No No No3 59

TABLE 6 ITEMIZATION OF IDENTIFICATI0ft AND CONTACT.BEING MAILED C-101 PACEMAKERS fl0T!FICATION NOTIFICATION RECEIVED RECEIVED SERIAL DATE OF MOS1 GRA:ELET AND INDICATING INDICATING EFFECTIVE fiUMBER RECENT FOLLOU-LF l'ERP t I:llT I.D. PATIEffT CARRYING PATIENT WEARIfiG CONTACT (CODED) EXAMIflATIOil C\\RJ MAILED? I. D. CARD? BRACELET? MAINTAINEE IN002272 11-18-77 Yes No No No3 1N001273 07-?5-78 Yes Yes Yes Yes 1N144277 03-il-78 Yes Yes Yes Yes 1N036278 11-18-77 Yes No No No3 1N003279 06-13-78 Yes No No Yes 1N036281 12-05-77 Yes No No No3 1N147283 03-24-78 Yes No No No5 1N059284 12-14-77 Yes No No No3 1N015285 12-08-77 Yes No No No3 lill47287 04-10-78. Yes No No No5' 1NQa6290 07-19-78 ,Yes Yes Yes Yes 1NO37291 04-03-78 Yes No No Yes 1N007293 04-03-78 Yes No No No5 1N002295 02-21-78 Yes No No No3 1N147298 06-30-78 Yes No No No5 1R145.302 02-21-78 Yes No No No3 1N029305 08-17-78 Yes No No No5 - 1NQ23206 02-24-78 Yes No No No3 1N146307 07-06-78 Yes No No No5 1N017308 07-17-78 Yes Yes Yes Yes 1N147310 03-07-78 Yes No No No5 IN147311 05-30-78 Yes No No No5 1N147312 03-22-78 Yes No No No5 60

TABLE 6 ITEMIZATION OF IDENTIFICATI0;l AND CONTACT BEING MAILED C-101 PACEMAKERS NOTIFICATION NOTIFICATION RECEIVED RECEIVED SERIAL DATE OF MOST BRACELET AND INDICATING IllDICATING EFFECTIVE NUMBER RECEriT FOLLOF1-UP' PERI 1ANEliT I.D. PATIENT CARRYING PATIENT WEARING CONTACT (CODED) EXAMINATION CARD MAILED?

1. D. CARD?

BRACELET? MAltlTAINEE 1N146313 07-03-78 Yes No No No5 1N145314 06-27-78 Yes No No NoS 1N147317 08-09-78 Y_es No No No5 1N147318 08-22-78 Yes No No No5 1N147319 03-28-78 Yes No No No5 1N147321 03-22-78 Yes No No No5 1N015324 06-06-78 Yes No No Yes 1N147327 07-03-78 Yes No No No5 1N14632_8 07-0 -78 Yes No No No5 110091001 02-22-78 Yes No No No3 1N1471002 08-17-78 Yes No No No5 1N1471001 07-11-78 Yec L No No No5 enumm- = 61

( NOTES FOR T/BLE 5 AflD TABLE 6 1. This is a recent implant. At the time of this report, the patient's identification card and bracelet had not yet been completed. 2. Continuing efforts are being made to contact this patient. s 3. Follow-up data duc during this six-month report period has not yet been received for this patient. Coratomic is undertaking continuing efforts to restore accurate and timely monitoring of this patient's racemaker. 4. This patient's jmplant registration form contained insufficient data for Coratomic to complete his or her identification card and bracelet A request has been mailed to the patient's hospital to obtain thp necessary information. 5. This is a recent implant. Follow-up forms are not yet due. e ( e e 6 (. 62

TABLE 7 DTIAtaTICN OF POST-IMPIAtHATION CCr@LICATION C-100 PACEMAKERS SERIAL DATE OF IEEER COtPLICATION CD@LICATION TREA'IMEtTT (CDDED) N001032A 07-15-76 Insufficient R-wave Explanted N001039A 03-07-75 Insufficient R-wave Explanted N001042A 07-10-75 Malfunctioning electrode Changed to second, previously implanted electrode N001042A. 12-15-75 Pacer pocket infection Pacemaker repositioned N001042A 03-28-78 Pulse generator showing Pacemaker repositioned signs of extrusion N003048A 12-05-77 Intermittent failure to Explanted sense N003057A 06-14-78 Hyperventillation Patient may require an AV sequential pacemaker for better cardiac output N0010928 11-14-75 Malfunctioning electrode Fractured electrode repaired N0010928 10-17-77 Possible tachycardia while Explanted being monitored N004097A 02-21-75 Insufficient R-wave Explanted ~ N008099A 04-18-75 Insufficient R-wave Explanted N005102B 09-13276 Intermittent change in Explanted Pacemaker rate N002108B 07-29-75 Intermittent failure to Electrode replacement, pocket sense revision N002108B 10-17-75 Insufficient R-wave Explanted N001121B 10-24-75 Malfunctioning electrode Explanted 63 t

TABLE 7 EXPIRATION OF POSFIMPIRTIATION COMPLICATION C-100 PACDEKERS SERIAL De'L"'E OF Nt2EER COMPLICATION 034 PLICATION TREADEC (CDDED) N005129B 12-22-75 Twitch in pectoral Corrective surgery, muscle set screw cap inserted N021143B 09-10-75 Insufficient R-wave Explanted N021149B 09-10-75 Insufficient R-wave Explanted

N00ll56B, 09-14-77 Inadequate sensing Electrode replacement N00ll57B 09-30-75 Malfunctioning Electrode repositioned electrode N00ll61B 12-15-75 Malfunctioning Electrode Replacement electrode N004170B 10-13-75 Malfunctioning Electrode replacement electrode D

en 64

TABLE 8 EXPIA%TICN OF POPIMPIANTATION cot 4 PLICATION C-101 PACEEKERS SERIAL DATE OF NUMBER COMPLICATION CCt4 PLICATION TREA'DEt7P (CDDED) 1N002005 02-10-76 Displaced electrode Electrode repositioned 1N0290ll 10-06-75 Malfunctioning electrode Electrode replaced 1N001014 10-28-75 Malfunctioning electrode Electrode replaced 1N012021 05-05-76 Loss of capture Explanted 1H002035 01-10-76 Displaced electrode Electrode repositioned 1N002037 12-12-75 Intermittent capture Electrode repositioned 1N034052 01-07-76 Patient had syncopal Pacer coated with silastic and episodes continous pactoral lead replaced, new set screw cap stimulation, intermittent inserted (cap not inserted sensing at the initial implant) 1N034052 01-09-76 Intermittent sensing Electrode repositioned 1N034052 11-03-77 Threatened erosion of skin Pacemaker relocated on 11-03-77 and 11-25-77 1N001056 08-02-78 Pulse generator extruding Pacemaker repositioned and through skin Parsonnet bag applied. Lead also repositioned 1N049061 06-04-76 Intermittent capture Electrode repositioned 1N049061 10-13-77 Pacemaker inhibiting when Electrode replaced 10-21-77 patient near electric frying pan or frozen food section 1N039095 09-07-76 Failure to sense and inter-Set screw plug placed in proper mittent muscle stimulation position 1N072096 12-16-77 Absence of pacer function Pacer replaced 65 n. b e E

TABII 8 EXPIRATION OF POST-IMPIAVIATION CWPLICATION C-101 PACDRKERS SERIAL DME OF 1REER COMPLICATION C04 PLICATION TREA'IIIEtE (CODED) 1N041100 06-07-76 Intermittant capture Electrode changed, set screw plug refitted 1N056108 04-14-76 Intermittant sensing Spontaneous remission 1N001114 03-30-76 Malfunctioning electrode Electrode replaced 1N009116 09-01-77 Sensing of rayopotentials Second pacemaker was implanted on left side 02-22-78 lN043123 08-11-76 Intermittent sensing and Electrode repositioned capture 1NO30126 07-21-77 Intermittent reversion to Pacer replaced magnetic rate 1N072127 10-13-76 Intermittent reversion Pacer replaced to magnetic rate 1N001131 4-78 and Several blackouts 5-78 1N030133 11-26-76 Electrode malfunction Pacer replaced 1N089157 08-30-76 Intermittent sensing Electrode replaced 1N048174 06-03-77 Pectoral muscle stimulation Patient refused to have anode cover installed. Problem diminished and is no longer disturbing to patient. 1N098179 11-17-76 Intemittent stimulation of Pacer coated with silicone mga muscle at generator site causing twitch 1N098179 09-12-77 Discomfort at pacemaker site Pacemaker explanted 1N057193 02-01-77 Electrode displacement Electrode repositioned 1N046250 02-28-78 Fatigue for 3 - 4 weeks Condition now improved 66 ..a.

TABIE 8 EXPIMCIW OF POST-IMPIRTECIOT COELICATIG1 C-10lPACErnKEas SERTAL DATE OF NGEER CGPLICATION CWPLICATION TREA'HD7T (CODED) 1N141266 11-01-77 Occasional failure to Electrode repositioned capture IN046290 06-26-78 Occasional light headedness e 67 .. __ e . _._t . ~.

2 i TABIE 9 ITDEZATION OF ETIR,TS C-100 PIC W TAS SERIAL DATE OF PDAL DISPOSITIG1 IGEER IC DVAL/ MIICIM OF PICWIR (CODED) PATID,7 DEATil N001032A 06-08-76 Insufficient R-wave Returned to Coratomic-within specifications N001034A 10'17-77 Patient death Returned to Coratomic-within specifications ( N001029A 03-07-75 Insufficient R-wave Returned to Coratcmic- \\. Within specifications N003048A 12'-05-77 Intermittant failure to Returned to Coratomic-sense within specifications N002052A 07-09-77 Fatient death Returned to Coratomic-within specifications N002053A 01-01-78 Patient death Returned to Coratomic-wi; thin specifications N003054A 03-02-75 Patient death--no autopsy Returned to Coratomic-performed within specifications N001092B 10-17-77 Possible tachycardia while Returned to Coratomic-being monitored within specifications N004097A 02-21-75 Insufficient R-wave Returned to Coratomic-within specifications # N008099A $04-18-75 Insufficient R-wave Returned to Coratomic-within specifications N0021085 10-17-75 Insufficient R-wave Returned to Coratcmic- { within specifications N00ll218 10-24-75 Because of C-101 availability Returned to Coratomic-C-100 was replaced by C-101 within specifications during a lead replacement 68

t TABII 9 ITDiIZATIOJ OF ETIAmE C-100 FI m nKEPs SERIAL DATE G' FIIAL DISPOSITIQ1 NGEER IDDVAL/ ETWETIOJ og pACDR}TJ1 (CODED) PATIEN'T DCNTl! N005102B 09-14-76 Intermittent change of Returned to Coratomic, pacemaker rate complication not duplicate Wire fragment found within pacer N021143B 09-10-75 Insufficient R-wave Returned to Coratomic, within specifications N021149B 09-10-75 Insufficient R-wave Returned to Coratomic, within specifications N00ll63B 08-30-78 Patient death Returned to Coratomic, within specifications N004167B 06-12-76 Patient death Returned to Coratomic, within specifications l 69

TABIE 10 ITDil7MIQ1 OF EXPIR.TS C-101 PACD4TJIRS SERIAL DATc or FIraL DISPCSITIa1 te'J3ER IO UVAL/ EXPIRMTICTI OF P7C247dIR (CODED) PATID.T DT.WIll 1N001014 04-12-78 Patient death Retur'ned to Coratomic, within specifications 1N001020 06-08-76 Patient death - cardiac Returned to Coratomic, arrhythmia within specifications 1N012021 05-06-76 Loss of capture Returned to Coratomic, broken wire IN029027 08-17-78 Electrode malfunction Returned to Coratomic,. within specifications 1N033038 02-14-76 Patient death - acute rayocardi al Returned to Coratomic, infarction within specifications 1N030062 03-09-77 Patient death Returned to Coratomic, within specifications 1N023067 08-08-76 Patient death Returned to Coratomic, within specifications 1N001072 07-09-77 Patient death Returned to Coratomic, within specifications 1N023085 05-27-77 Patient death Returned to Coratomic, ' within specifications d 1N072096 02-20-77 Absence of pacer function Returned to Coratomic, insulation fracture in i transformer l 1N023109 08-17-78 Failure to capture - spliced Returned to Coratomic, l electrode within specifications 1N001120 10-18-76 Patient death Returned to Coratomic, within specifications 70 -.. - ~.. r

TABII 10 rm1IZM' ION OF EXPIRES C-101 PACDGKERS SERIAL DATE OF FIIAL DISPOSITICU NGE1ER IO m74/ EXPIRATIW G' PACDnKETI (CODED) PATII23' DDTTl! 1N030126 07-21-77 Intermittent reversion Returned to Coratomic, to magnetic rate solder joint failure IN071127 10-14-76 Intermittent reversion Returned to Coratomic tv magnetic rate solder joint failure 1NO30133 11-26-76 Electrode malfunction Returned to Coratomic, within specifications 1N100136 03-10-78 Impending erosion of pulse Returned to Coratomic, generator within specifications 1N004172 '01-03-77 Patient death'- acute Returned to Coratomic, rayocardial infarction within specifications 1N098179 09-12-77 Discomfort at pacemaker site Returned to Coratomic, within specifications 1N030181 03-03-77 Patient death Returned to Coratomic, within specifications 1N002292 08-15-78 Patient death Returned to Coratomic, within specifications 1N100297 05-03-78 Exit block observed Returned to Coratomica within specifications I i i i i 71 l _x

'D\\BIE 11 ImczATIcti cr rTuerna cr:.vC::7Cr:tc Pct.ucD P7c'sEns (CC:!ITCL C:UJP) ILTel It.. DN:I: CF K3E CP PIC ? ASSIG:ED FirT P&Ctr D TIM T"n E PATIE7" SCR.7CI 1.Um EDIlD;M1P PI G N'ER D:STI W TIO In'IZ CF AT DWS) T! (Q2CCD) CCIImTIOtt CESCRTEr!C'1 (CCDCD) nTInts DIPUJIT CF !~v.~PC' CO:MllTICt:71 IO.T.T7.D PACI2t%E6 DJ SEISFTC:Diu' SCPNICC C001001 11-04-75 s Demcnd 001 03-05 75 67 1,274 C001003 05-21-76 Demand 001 11-20-74 60 1.379 C001004 10-02-75 Demand 001 02-20-75 61 1,287 C001005 06-28-76 Demand 001 10-03-74 45 1,427 C001006 02-03-76 Demand 001 01-15-75 59 1,323 C001008 06-01-76 Dem nd 001 04-30-76 62 1,218 ( C001009 01-16-75 Demand 001 10-25-74 64 1,405 C001010 02-15-76 Demand 001 12-11-74 Unkncwn 1,358 C001011 05-15 Demand 001 01-17-75 53 1,321 COOP 05-27-75 Demand 001 03-27-75 58 1,252 1,266 C001(13 11-04-75 Othert 001 03-13-75 , 70 C001014 08-11-76 Demand 001 05-09-75 49 1,209 C001015 06-08-76 Demand 001 05-05-75 69 1,21 3 C001016 02-15-76 Cemand 001 07-31-75 86 1,126 C001017 02-15-76 Demand 001 08-13-75 63 1,113 1,129 C001018 09-16-75 Other 001 07-28-75 Unknown I 'I4I C001019 06-02-76 Demar.d 001 07-16-75 74 1'097 C001020 02-15-76 Other 001 08-29-75 57 1 1'087 C001021 02-25-76 Demand 001 09-08-75 69 1,0% C001022 02-15-75 Demand 001 09-15-75 80 1,086 C001025 03-30-76 Demand 001 09-09-75 73 C001026 09-23-75 Demand 001 08-16-74 56 .1,475 72

e n BIE 11 TITMI'IsTIC t GF ETLNTfCD C:':VC.'"IO:TC, PC.. w PICCVJCPS (CLTPCL CTCG) rrrvri2 DE CF ACE OF PIC 7 ASSIGGL PCST TCCD.T D*PLN, TOC PA E T S?.aTF C ~ ?.UGER FOL*DMP PACD'N'EP. D:STIETICN r;c CF AT CAYS) 71 (CXCD) D:A:4E LTIG1 CESCRIITIG1 (C DED) nep;g,7 D' PIN.T CF FIFO. CGM 2,TICAL FG.TT.D PACC? DIPS E! SATISTIC'OtTi SC'WICE C001027 12.-20-75 Demand 001 16 74 56 1,531 C001029 02-24-76 Demand 001 24-19-74 36 1,594 C001030 05-18-76 Other 001 35-06-74 57 .1,577 y .C001032 12-02-75 Demand 001 LO-15-75 60 1,050 C001033 01-06-76 Demand 001 11-13-75 56 1,021 C001034 07-06-76 Demand 001 11-13-75 67 1,021 C001036 02-03-75 Damand 001 31-26-76 77 947 i C001037 02-02-76 Demand 001 21-23-76 72 950 C001038 03-02-76 Demand 001 21-21-76 60 952 C001039 05-19-75 Damand 001 34 28-75 64 1,220 C001040 03-19-76 Demand 001 33-19-76 61 895 C001041 03-13-76 Demand 001 31-29-76 '69 944 C001042 07-09-76 Othery 001 37-09-76 50 783 C001043 01-16-76 Other 001 31-16-76 70 957 y C001044 11-24-75 Other 001 ll-24-75 71 1,010 C001045 05-11-76 Demand 001 35-11-76 58 842 C001046 11-22-76 Other 001 33-29 -76 63 885 C001047 06-29-76 Demand 001 )6-29-76 59 793 C001048 06-28-76 Demand 001 06-28-76 60 794 C001049 01-26-76 Demand 091 31 76 49 947 (- C002001 07-07-76 Demand 002 37-10-75 78 1,147 C002002 05-01-75 Demand 002 p3-14-75 81 1,265 C002003 00-11-76 Demand 002 07-09-74 74 1,51 3 73

~ UEIZ 11 IIDtIZATIGi CF ETLY.T4D CC:NI27."ICI:71 PCT.!ED PIC!?JIPS (CDNITCL GTCUP) CWv'CI;. a InTZ CF ACE OF P7C 'A ASSIG 3 FCGT FSCR.T IMPLV Ti'U.T. PAT 2r.' SEIU!"" ! W._'CR IUJGI-CP PICN'ER D STI"LT!tr. CATE OF AT INIS) ' !. (CDOZD) C<leID ATICtl CCSCRIPTIC:1 (CCC::D) nTLYtr n TIR77 CF IC?CR CO:NC.~rIGv*'i IG.UCD PICI;WEG nl 37CISTICCTT SI:iWIC: l C002004 04-08-76 Demana 002 la-05 J4 72 1,425 C002005 01-07-76 Der.und 002 C5-16.76 70 1,567 C002006 08 :11-?C Demand 002 Jo.a,1 74 go 1,419 C002009 08-P.3-74 Demand 002 03-13-74 84 1,478 C002010 08-12-76 Demand 002 03-29-74 66 1,615 C002011 05-20-76 Demand 002 07-17-74 44 1,505 ( C003001 01-14-75 Dccand 003 01-14-75 76 1,324 C003002 10-17-74 Demand 003 09-18-74 74 1,442 C003003 02-07-75 Demand 003 02-07-75 86 1,300 C003004 12-27-74 Demand 003 12-27-74 72 1,342 C003005 01 24-75 Demand 003 01-24-75 56 1,31 4 C0O3006 12-30-74 Demnd 003 12-30-74 61 1,339 C003007 02-05-75 Demnd 003 02-05-75 77 1,302 C003008 03-07-75 Demand 003 11-25-74 57 1,374 C003009 01-23-75 Demand 003 31-23-75 70 1,31 5 C003010 12-27-74 Demand 003 12-27-74 65 1,342 C0030ll 02-06-75 Demand 003 - 32-06-75 76 1,301 C003012 03-26-75 Demand 003 11-22-74 69 1,377 C003013 03-21-75 Demand 003 )7-10-73 58 1,877 C003015 02-14-75 Demand 003 )2-05-74 58 1,667 C003016 12-27-74 Fixed rate . 003 02-23-73 62 2,009 74 {

TADIE 11 2'IntI'itiTION OF DPWLID CC:NU.'"IO:76L PCtT.ED PICD%ERS (CXETOL GTCUP) ccTeTn3 CATC T IIC OF PI C 'd ASSIQED M 33T C.T DOWTD.O PA"TE E SFTTCZ hut 9.71 FOLICl-UP P/CnER I::STITUTICL CRTC CF AT CAYS) T~~ (CDT:D) CU'C:ATICti CSSCRIPTICI (CCCCD) D:PW.T D9w.T CF TCC Cc:Nc.TIu:71 mmo Pic1:WI:s I:3 SATISTIC:CW SI:WICE C003017 02-26-75 Demand 003 07-20-73 30. 1,867 C003019 03-25-75 Demand 003 12-31-73 42 1,703 C003020 03-07-75 Demand 003 12-19.-73 69 1,71 5 C003021 03-25-75 Demand 003 12-26-73 60 1,708 C003022 0.1-26-75 Demand 003 09-05-73 49 ],820 C004001 01-03-75 Demand 004 01-03-75 59 1,335 ( C004002 09-03-75 Demand 004 09-03-75 63 1,092 C004003 09-10-75 Demand 004 09-10-75 70 1,085 C006001 0549-75 Demand 006 05-03-75 83 1,209 C006004 04-01-76 Demand 006 06-26-74 65 1,526 c006005 05-26-76 Demand 006 08-11-75 .77 1,115 C009001 05-07-75 Demand 009 08-16-74 74 1,475 C010002 01-08-76 Demand 010 06-28-74 79 1,524 C012001 09-03-75 Fixed Rate 012 39-03-75 17 1,092 C012002 01-25-76 Demand 012 39-75 13 1,091 C013001 06-06-75 Demand 013 06-06-75 55 1,1 81 C015001 03-18-75 Demnd 015 04-26-75 70 1,222 CO21001 07-22-75 Demand 021 37-22-75 63 1,135 g CO21002 08-06-75 Demand 021 38-06-75 67 1,120 5 CO21003 08-18-75 Demand 021 28-18-75 57 1,108 C035001 02-04-76 Demand 035 39-30-75 Unknown 1,065 1 C001050 09-13-76 Demand 001 09-13-76 60 717 75 L

l TABIE II ITD!IZATIQ1 OF DPIAtEED CDINDEIQmL PGERED PICD!AFIRS ( (CDIETOL GIOUP) DUIRTIC:1 DATE OF AGE OF PICE'ITE ASSIGiED FDCT ICCD,"r DPIAER:G PATID E STJNICE ( i NWBER FOLIG1-UP PACDiMIR INSTITUTIO!! DATE OF AT DNiS) TH". (OODED) EXIMTIATICN DESCRIPTION (CDDED) IMPIIerr IMPIA?C OF REPORT 00iNDEIOtML P0.'ERED PACUnICRS Ill SATISFICIOTa' SERVICE t l C001051 08-15-77 Demand 001 08-15-77 65 381 i C001052 11-17-76 Demand 001 11-17-76 60 652 C001053 10-08-75 Demand 001 10-08-75 56 1,057 i (- 76 p

ABIE.11 UDII2ATIai cr ITIntIID CD:TJECIGAL F3ED PACDFJZFS (CIXTITCL GICUP) wF/CIC; DNIE CF AE OF PI C 'A AssI m m s T. m,T neIRnT:C PATIn.T SUMC NtDTIR K"IUf-UP PACC W'IR E SITILTIG CATC CP TC ELYS) '~I (cm m) et;.u nTIat czscR:PTIai (coc D) nerug ne: ANT CP m CouncIG:AL Ic.mo PAcriteZRS :D IrN2R IN SER/ ICE C001002 Other 001 04-02-75 68 4022 y

C001007 Demand 001 10-21-75 58 3762 C001023 Demand 001 09-08-75 71 139 2 C001024 Demand 001 04-16-76 19 5042 C001028 Demand 001 03-12-7E 35 7602 ,C001031 Demand 001 02-08-7E 73 172 2 ( C001035 Demand 001 12 06-75 59 0562 C002007 Demand 002 07 23-74 66 7922 C002008 Demand 002 01-24-75 61 1 2 C003014 Fixed rate 003 04-12-73 59 8202 C003018 Demand 003 10-23-72 56 9042 C006002 Demand 006 07 18-74 76 3942 C006003 Demand 006 06-20-74 51 5092 C010001 Demand 010 09-17-74 69 4272 I Pacmaker description not iientified { 2 Duration of pacemaker service (in days) before removal 77

rNu.t: 12 Mutt:%TIGJ OF Ir/JJ l'!/r!M2tr (~ CIEVI:TIctsi ro.:: RED PTCWIIG (ccurioL crrt.r)

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n t-m 2._ _, _ :. PTER t J '/.D I 12.'D G;:- Wrf It-Dmmit- .WOf/O-ir: ..U2Cl touro) n Pr/e r I rt/ct: !:rr l IJW1 T.!n7dliIf Y! (.wa:.<. t r.tn.) i

gr.

nIta. nI/e, or/J. CCNVD.TICPL PChHCD PICMPs IN S;.7. 5F/CICE' SEI& ICE C001001 03-05-75 03-05-75 Unknown ) C001003 11-20-74 11-20-74 Medtronic 5901 X C001004 02-20-75 02-20-75 Medtrenic 6907 X C001005 10-03-74 04-72 Medtronic } C001006 01-15-75 01-15-75 Medtronic 6907 C001008 04-30-75 C4-30-75 Cordis X C001009,10-25-74 10-25-74 Unknown X C001010 12-11-74 12-11-74 Medtronic 5946 X l I C001011 01-17-75 01-17-75 Unkcown X i 901012 03-27-75 03-27-75 Medtronic X l C001013 03-13-75 03-13-75

Medtronic X

i C001014 05-09-75 iO5-09-75 Cordis X l 3 C001015 05-05-75 05-05-75 'Medtronic 6907 X C001016 07-31-75 07-31-75 gedtronic6907 X M C001017 08-13-75 '08-13-75 Medtronic 6907 X C001018 07-28-75 11-01-71 Medtronic X C001019 07-16-75 07-16-75 Medtronic 6907 X C001020 08-29-75 1972 Unknown C001021 09-08-75 09-03-75 Medtronic 6907 X' l l C001022 09-15-75 Jnknown .Medtronic 6907 X i C001025 09-09-75 29-06-73 Medtronic 5901 X i ( 001026 08-16-74 28-16-74 Medtronic X l j06-21-74 06-21-74 'Medtronic 6901 J01027 'X i I i C001029 04-19-74 D4 74 Mi edtronic X 78 I

i! "JditI 12 I I'IT2'.I ATIGl CF I. AD P!/CM2.T C Q W Q TrIQ 7J, M.'EPZ D P?CE M I PS (CCetrIDL GTG.9) ..,5IGED UA'IT. OF iWit CF i:Hi"JI AR pl-PJ" w !D: DER PJ4'ER LI70 IEAD CCCtIPTIul D."1 CTui- .WO7Ji-C.IXr/Ji- .WCG.R 4 (Coom) DOIR.T PI/LTM2tr (m'r. 6 : Crc.)

ntN, DIM,

CIM, O rc. ' C CnuE2:rIQaL Inw P;czmIPS IN E7CISF;c:cnr SF_WICE C001030 05-06-74 04-26-74 Medtronic 6917 X

C001032 10-15-75 10-15-75 Medtronic 6907 X C001033 11-13-75 11-07-43 Medtronic X C001034 11-13-75 11-13-75 Madtronic 6907 X C001036 01-26-76 01-26-76 Medtronic 6901 X C001037 01-23-76 01-23-76 Medtronic 6907 X ~ C001038 01-21-76 Unknown Medtronic X C001039 04-28-75 04 75 Unknown X ( (201040 03-19-76 03-19-76 Caratomic L-20 X 001041 01-29-76 01-29-76 Medtronic 6907 X C001042 07-09-76 07-09-76 Medtronic 6907-58 X C001043 01-16-76 Unknown Unknown X C001044 11-24-75 Unknown Unknown X C001045 05-11-76 05-11-76 Medtronic X C001046 03-29-76 Unknown Unknosm X C0010'47 06-29-76 06-29-76 Medtronic 6907 X C001048 06-28-76 06-28-76 Madtronic 6907 X C001049 01-26-76 01-26-76 Medtranic 6917 X C002001 07-10-75 07-10-75 Medtronic 6907 X C002002 03-14-75 05-25-73 Biotronik IEK-60 X C002003 07-09-74 07-09-74 Cordis 62cm/2:mi X M02004 10-05-74 10-05-74 Cordis 62cm/4r:m X ( 2005 05-16-74 05-16-74 Cordis 62cn/2r=1 X l C002006 10-11-74 09-29-71 Cordis 62cm/2::n X 79 I m

TABLE 12 I'ID4ILTTICt! OF LDO Pt./DC.*r ( converncwa rom Pic;s;Ps (CO.TIOL GTOL"P) ASSIGED CICE G DATE C L?lIlf Ult 1 B !-POUJ< ' 3: IC:GER PICER LDD LEAD CESCRIPTICM C COC1Jt- : riCG.R-t C:WC/.R-6 : F.L.-5.-t ;c; (CrDED) D?U2 *" PUCF:C.T, (.'*1J2 t. :* COTE.) DDL DD1 I OD.L i DII' I c--, C002009 08-13-74 08-13-74 Cordis 62cm/2mm X l '002010 03-29-74 03-29-74 l Cordis 62cm/2m X C C002011 07-17-74 08-72 Cordis 62cm/2m X C003001 01-14-75 03-07-68 Modtronic X C003002 09-18-74 09-18-74 Cordis X 'C003003 02-07-75 Unknown Cordis 2m X C003004 12-27-74 Unknown Cordis 2ca X C003005 01-24-75 01-24-75 Unknown X 003006 12-30-74 Unknown Unknown X c' 3007 02-05-75 02-05-75 Cordis 2x X C003008 11-25-74 11-25 Unknown X C003009 01-23-75 01-23-75 Cordis 2mu X C003010 12-27-74 12-27-74 Cordis 2.Tra X C003011 20-06-75 02-05-75 Cordis 2m X C003012 11-22-74 Unknown Unknown AX C003013 07-10-73 07-10-73 Cordis 2mm X ,ll C003015 02-05-74 02-05-74 Cordis X C003016 02-28-73 02-28-73 Cordis 2mm X C003017 07-20-73 03-26-71 Cordis 2mn X C003019 12-31-73 12-31-73 Medtronic X C003020 12-19-73 12-19-73 Medtronic X, ( 3021 1, 2-26-73 12-26-73 Unknown X C003022 09-05-73 Unknown Cordi; 2m X C004001 01-03-75 01-03-75 Unknown X 80 i,

TABIE 12 I'IU4tLVIO OP LE;O PUCCC."r ( cwvwrICr:a torcaEo P;c.scrs (CORTOL GDOCP) .~ 'i ASSIC:ED ILn; CF ClaE Ol' LN11C U.R DI-PO UR i ifJMBER PICR IIAD LCTO CCSCRIT'r!GJ C.Ed-TiZiR-4:::lCG.i:- : ~YJ .<-( ?? (CCED) D~3U2.~r P U C C O.'" DW'E & I'CCEL) 'DTM, DIE I O Ud., ' DT.' ~, ' 7/G e I l Unknown I 'X C004002 09-03-75 Unknown s C004003 09-10-75 Unknown ' Unknown X C006001 05-09-75 05-11-73 B,iotronik IEK-60 X l C006004 05-2G-74 06-25-74 l Cordis 62cr/2rnm X C006005 G3-11-75 07-05-72 i Cordis 62cm/2m X C009001 08-16-74 08-16-74 iCordis 62cn:/2a X C010002 06-23-74 06-28-74 Cordis 62cm/2:a X C012001 09-03-75 09-03-75 Medtronic 6917 .X C012002 09-04-75 09-04-75 CPI X .C013001 06-06-75 06-06-75 Medtronic 6907 X (i C-5001 04-26-75 04-26-75 Medtronic X us21001 07-22-75 07-22-75. Medtronic 6907 X CO21002 08-06-75 08-06-75 Medtronic 6907 X CO21003 08-18-75 08-18-75 Medtronic 6907 X C035001 09-30-75 Unknown Unknown X C001050 09-13-76 09-13-76 Cordis X C001051 08-15-77 08-15-77 Coratomic L-40 X C001052 11-17-76 11-17-76 Medtronic 6917 X C001053 10-08-75 10-08-75 Cordis X l 81 1 j i

Jl 'I'N ti.!: 12 InMI:'ATI0t1 CF IJA!s l'!n'tM Trr

(-

CONDT.'IGZL m'ED P?C?l2PS (CCUTTD'., ( EUP) tEIG;ED iicn oie iwit iit' ; ia L ml ail _ _a __ l'L-t*S L cGCCa PTCER IJAn IEAD P!Tctll'rItrl 12.'1IY Alt-MY(CNt-CUrAR- .TiICid M 2; P!/4.*!:'! fr (>'AK!: 1. et Vil'J.) DIAR. titN. DITL Dil L ' O (contr) Sm.r CCCNE:11'ICUL FGEM:D PIC'1JIPS 10 ICIC IN SE-{/ ICE C001002 04-02-75 07-69 Medtronic C501007 ~ 10-21-74 10-21-74 lliedtrenic 6907 X C001023 09-08-75 09-03-75 Medtronic 6907 X ' N C001024 11-29-74 11-29-74 Medtronic 6933 C001028 02-11-74 04-72 Unknown C001031 08-20-75 08-20-75 Medtronic 6907, X C001035 12-16-75 12-16-75

Medtronic 6907 X

!, Cordis 62cm/2mm C002007 37-23-74 10-22-68 X ! ordis 62cm/2m c002008 31-24-74 01-24-74 C X (- 33014 M 73 12-03-65 Cordis C003018 12-23-72 10-23-72 Unknown i C006002 37-18-74 i07-05-72 Cordis 62cm/2m X C006003 )6-20-74 06-20-74 Cordis 62cm/2mm X C010001 29-17-74 09-22-72 Cordis 62cm/2mm X I a e ( l. 1 82 i

TABLE 13 I2PIR;ATIC:1 G' IOST ITTU(frATIG3 COTLICT. TIC:1 CD NCTrIOCL;L PCtEFED PACCWTRS 00tTJOL CTCUP Assigned 16. Date of (Ccxicd) Ccrplication' Canplication Treat =nnt C001006 01-27-76 Malfunctioning pacemaker ' liew pacemaker system - s serted on right sice using old pacemaker C001013 03-14-75 Diaphragma tic pacing Repositioning of pace-maker electroce C001013 11-04-75 Diagnosis of lef t pleural effusion probable post peri-cardiotomy syndrome C001017 '09-75 Malfunctioning electrode ! ead change to unipolar L (i C001019 07-22-75 Malfunctioning pacemaker l Repositionino of i electrode l Malfunctioning pacemaker l Lead repositioned C001021 02-20-76 C001022 09-15-76 Malfunctioning pacemaker Lead repositioned C001024 04-16-7G Lead fractured Explanted C001027 01-05-75 Migration of transvenous Reloca ti,on of pace-pacemaker battery with

maker erosion through the thinned i skin C001028 02-17-76 Pacemaker has dropped causing Scheduled for change i pain pacemaker C001028 03-12-76 Malfunctioning, shif ting of Explanted 1

pacemaker causing pain C002005 05-18-74 Malfuncticning pacemaker Reposition of lead g C002007 09-24-76 ' Possible pacemaker failure . Explanted C003004 07-11-75 Battery exhaustion Explanted ( 1003018 04-15-75 Change in all pacemaker Explanted f parameters ti C006002 ~ 08-11-75 Inadequate sensing Explanted 5 l I l Episodes of failure to sense l Explanted t C006003 11-11-75 83

TABIE 14 [ ITULIZAT*CN OF EXPIRG t-CCtNDEICtD.L IU.~CPC PACD?Kr.PS [ CIXCTOL CTCUP i i 9 - Assigned 16. Date of Pe cval/ J

j (coded)

Patient reath { Explanaticn j \\ o 1 i C001002 01-29-76 Possible defective pacemaker C001007 11-75 Patient death--cause unknown C001023 01-24-76 Patient death--ccronary crtery disease l C001024 04-16-76 Pacer replaced with C-101 because of leM failure C001028 03-12-76 e t Palfunctioning, shif ting of pccomaker caus:r. C001031 02-08-76 pain ~ Patient death--cause not indicated in I no tifica tion I C001035 02-10-76 ( Patient death--cause unknown ( C002007 09-24-76 Possible pacemaker failure C002008 01-24-75 Patient death--patient developed ventricular fibrillation approximately 4 hours af ter implantation C003014 07-11-75 Battery exhaustion .C003018 04-15-75 Change in all pacemaker' parameters C006002 08-11-75 Pacemaker sensing problems C006033 111-11-75 Pacemaker sensing failure C010001 11-17-75 Premature battery exhaustion l t j 84 I '}}

ML19281A129

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