ML20235S704

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Provides Listed Info in Response to Request for Addl Info Re Application for Renewal of License
ML20235S704
Person / Time
Site: 07002205
Issue date: 05/10/1976
From: Howe G
ST LUKE'S MEDICAL CENTER, MILWAUKEE, WI (FORMERLY
To: Vacca P
NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
Shared Package
ML20235S679 List:
References
NUDOCS 8903070226
Download: ML20235S704 (10)
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Text

{{#Wiki_filter:- g,,e/ d ' FECp i 9 w. g g } 2900 WEsf oKL A HoM A AVENUE /) PHONE 647 6423 ospilpdOIJ, K. itwAVKEE. WiscoNslN $321s y 4 May 10,1976 9 8 \\ O -2 4 */ g4y Ms. Patricia Vacca g#, 8 Radioisotope Licensing Branch Q - Division of Fuel Cycle and Material Safety qM-b s J United States Nuclear Regulatory Commission / g P Washington, D.C. 20555 cn

Dear Ms. Vacca:

This is in reference to Docket No. 70-2205 and your request for additional infor-mation before continuing to process our request for a license to participate in a clinical evaluation of the Cordis plutonium-238 powered pacemaker. j To further clarify the frequency of follow-up and our method for obtaining all the 1 data required on the Cordis Follow-up Data Form, we supply the following information: Pacer monitoring and patient follow-up will be performed for each patient receiving a nuclear pacer by two separate and independent methods. Both methods will supply s the team physician responsible for, thirstudy, as well as the patient's own physician, with data necessary to satisfy the requirements of "The Master Protocol for Evaluation I of the Programmable Cordis Nuclear Omni-Stanicor Pacemaker" of October 30,1974. More specifically, follow-up will comply with the directives set down in Section Ill, Sub-section F of said protocol. Complete information will be supplied on the forras in Appendix B, pages B-2 through and including B-9 of the master protocol. Follow-up information will begin to be gathered immediately at the time of implant. The equipment our institution uses to test the performance of a pacemaker is the Medtronic 5300 Facemaker System Analyzer. This device is used during implantation, to determine optimum voltage and pulse width thresholds with the resultant current flow. It will also display R-wave amplitude sensed by the implanted electrode to determine sensitivity threshold. The device con also be used in troubleshooting situations by determining changes in these parameters. The analyzer is also used to check the parameters of an implanted or removed generator. The same equipment and related procedure would be used to test the performance of the nuclear pacemaker at the time of implantation. I am including a copy of the form we use for documentation. This information will be supplied to the Cordis Corporation on Form 1, Appendix B of the Master Protocol. 8903070226 880201 REG 3 LIC70 GNM.1638 PNV The calscuss represents the medicd profession. The sphere represents the world uide scope of the L 9-medicd pratice, and the winged cdl with the hdo n the utepted ecclesiastics symbol <>f the sari. ficid netsre al Sit. Lske, the Apostle Physician. Thus, the mobde personifies 51. Lakds llospisd. A N O N - P R O P t 7 o ft G A N 1 Z A T I O N

v m 73 V ! ) 8h;^gi$lm Page Two May 10,1976 If the physician directs a more frequent follow-up, this will be done; however, information will be supplied only as set down in the protocol. This policy is adopted for the purpose of consistency and continuity of the study. One method of follow-up will be our Pacemaker Clinic. A patient's physician may request that follow-up be done in the pacer clinic. Upon receiving this request from the physician, clinic technicians will make an appointment with the patient for their 1 clinic visit. When a patient arrives for his first monthly checkup (for first visit only) he is admitted to the hospital as an outpatient. Standard outpatient information is obtained at this time. l l Pacer clinic visits are scheduled from 3:00 P.M. to 5:00 P.M. on Thursdays and are of fifteen minute duration. During the first visit a Pacemaker Clinic Data Record (copy attached) is made for the patient. Information on the patient's next of kin (name, i address and phone number) is taken and kept in the patient's clinic file. The first order of business during the clinic visit is for the clinic technician to inquire as to the patient's health and physical status. Specific checks are made relative to dizziness, blackouts, palpitations, irregular pulse, and current prescribed drugs. If j any serious problem is noted, the patient's physician is notified prior to clinic evaluation. If no complications are in evidence, the patient is connected to the following equipment via the traditional arm and leg limb leads. ^ 1. Hewlett-Packard 1500B EKG (permanent record of EKG wave form and pacing pulse) i l 2. Hewlett-Packard 21504A Signal Splitter (selects system display of l pulse width or pulse interval) j l 3. Hewlett-Pockard 7803B Monitor Scope (visual oscilloscope display of EKG wave form) i 4. Hewlett-Packard 1207B Oscilloscope (variable persistence display i of pacer output pulse shape) 5. Hewlett-Packard 197A Oscilloscope-Polaroid Camera (permanent record of pacer output pulse shape) 6. Hewlett-Packard 5326A Counter (digital display of the pulse width l or pulse interval) l This information is obtained from the above equipment: j 1. Permane < record of EKG 2. Permanent record of output pulse shape 1

(~) V Q Page Three' W ~ May 10,1976 These two items are kept for comparison with the records obtained during subsequent visits. If there is no change between the first and subsequent recordings, the sub-sequent recordings are discarded. 3. Digital information of patient's rate 1 4. Digital information of pacer's rate (with magnet) i 5. Digital information of pacer's pulse width 6. Digital information of pacer's pulse interval Digital information is maintained for each visit in the patient's Pacemaker Clinic Data Record. l During a clinic visit, patients may have their pacers reprogrammed, using the Cordis Omnicor Programmer #306-120. Or a magnet may be placed over the pacer to cause it to emit pacer pulses for evaluation, in the event that the patient's own rhythm is l inhibiting the pacer. Sensing may be evaluated via the method suggested in the Omni-l Stanicor Pacer Manual. This would require the use of a Medtronic 5880A or Cordis Chronocor 111, external pacer, alligator clip lead extensions, and disposable skin electrodes for the purpose of chest well stimulation. All three of these procedures are performed by physicians and not clinic technicians. After the pacer evaluation tests are performed, the information is recorded in the patient's file and supplied to patient's Cardiologist for his evaluation of the data. Before the patients leave the clinic, they are advised to keep their registration card with them and are checked to insure that they are wearing their I.D. bracelet or necklace. The physician releases the patient to leave the clinic provided that no serious health problem exists. The patient receives his next clinic appointment and then leaves. Another method of follow-up will be the routine scheduled visits at the Cardiologist's office, if pacer malfunction is detected, or a serious health problem is present, immediate arrangements are made to admit the patient to the hospital as an inpatient. If the pacer must be explanted, it will be done in accordance with Section 111, Sub-section G, Form 3, Appendix B, and Appendix G of the Master Protocol. Before explantation and disposal of the nuclear pacer, the patient's study team physician will evaluate the pacer by standard techniques to confirm the malfunction. l l The other method of pacer follow-up will be provided by Cardiac Datacorp, Inc. of Philadelphia, Pennsylvania. This transtelephonic pacer monitoring service will supply all physicians who have a need to know, with information on pacer function. Each nuclear pacer patient will be instructed in the use of the CDI transmitter and be familiarized with I l the service before leaving the hospital. This instruction will be done by hospital nursing \\

? t 5 (~/ U Pass Four - g l May 10,1976 } l personnel. When the patient returm home, he will receive his own transmitter through the mail within two months post implant. The patients will call in via commercial telephone to CDI on the following call schedule: J CDI Schedule C-Nuclear Pacer Units 1-12 months post implant - every two months 13-18 months post implant - monthly 19-30 months post implant - btweekly 31 months to failure - weekly When a patient calls in, information such as patient pulse, pulse to pulse pacer interval l l (with and without magnet) and recorded evidence of pacer capture are documented. This information is obtained on CDl's EKG recorders and pulse counters. The data collected is reviewed by the service's medical and technical staffs prior to sending infor-motion to the patient's physician (s). Information is supplied on a cumulative report i (sample enclosed) via the mail. If the data collected indicates that the pacer is functioning properly, the CDI report is issued within 24 hours of the coll. If a pacer malfunctions or indications of a battery l depletion are detected, the patient's physician (s) is notified within fifteen minutes of i l the call. The CDI service will serve as a double check en pacer clinic findings, as well as serve as another means to follow the nuclear pacers. This service will aid in maintaining location l status of nuclear units. it will be particularly helpful for out-of-town and restricted mobility patients. l Double documentation will be maintained in each nuclear pacer patient's file. This will insure that adequate and updated information can be supplied to the Cordis Corporation so that the requirements of the protocol are met. The following procedure will be initiated by the telephone operator upon receipt of any pacemaker call: INSTRUCTIONS FOR TELEPHONE OPERATOR l Instructions to Operator:

1. Accept all incoming collect calls with reference to "A Radioactive Pacer", "A Nuclear Pacer", or "An Atomic Pacer".

I

2. Any call concerning a radioactive pacemaker requires immediate action in order to avoid danger of radiation exposure and to insure l

recovery of the radioactive pacemaker. 1 1 t ._.._______m

..y. -Q t ~ '. Pags_ Fiva-

  • May 10,1976 -

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3. Obtain as much information from the coller as' possible, including:

Incident Precipating this Telephone Call-1 j s> ' Caller's Name j Address Where He May Be Reached Telephone No. 'l Patient's Name . Address Where He May.Be Reached Telephone No.

4. Obtain this information from the patient I.D; card:

Physician's Name Patient's Address Patient's Telephone No. .r Social Security No. Pacemaker Type: Cordis Nuclear Omni- -] l Serial No. j Date of implantation i

5. Notify above physician and nursing supervisor.

i

6. If physician can not be reached, contact physician on duty for the

.J l Coronary Care Unit. j L 'i l

7. Call Cordis Corporation: 1-205-578-2000 (24 hour telephone service) d
8. Forward this information to the switchboard supervisor.

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9. The switchboard supervisor will forward this form to the Cath Lab.-

-i l l hope this will supply the necessary information and that our request for licensure l will continue to be processed. i l Sincerely, 'I [ .l G. Edwin Howe President 'I GEH:li Encls. l -i i I

new implant O replacement implant O + Model 5300 Pacing System Analyzer (PSA) Data Form Patient name: Implanting physican name: Date of implant: File no: Implanted Lead Data Model no: Serial no: Manufacturer: Type (myocardial - endocardial) (bipolar - unipolar) (acute - chronic) Pulse width setting of PSA ms. Neg. Pace Threshold Terminal Volts to capture Resultant current R wave reading Unipolar tip electrode v mA mV Bipolar tip electrode v mA mV ring electrode v mA mV frent Lead Impedance PSA voltage Resultant current R= x 1000 Bipolar 5v mA C Unipolar Sv mA C Pulse Generator Data New unit Removed unit Manufacture r Model no: Serjal no: Type ( Asynchronous, Ventricular Inhibited, Ventricu!ar-Triggered, Atrial Triggered) Pulse Amplitude mA mA Pulse Interval ms ms __ Pulse Width ms ms Sensing properly? O yes O no O yes O no Notes A strength duration curve may be charted on the re"erse side. MC 7434dh 172308-001 Rev B

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<v Ct. Lune,'s'N8 spital (. ACEMAKER CLINIC-DATA RECORO N Milwautta, Wisconsin .X-409 Private M.D. Name Cardiologist ilospital Number Surgeon Medical Record Unit Number Date of Implant Date of Birth Manufacturer Date First implant l Number Model Underlying Rhythm Serial Number Refractory Period Type Threshold h'n't s i Date Month Interval Magnet Capture Sensing Comments .l m -l l J. l ) l =- h.y " -. ii. > C m Patient & next of kin adress and phone number n.m... e ne E O OU $ N $ f lI I (-

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c g gENthTE5N$5N$35NNbN N 5 % ~xb_=d 4= YE AR: ' 7 2 0 t / $ 4 6 6 7 8 9 10 11 12 1314 l',,16 17 16 19 20 2122 23 24 25 26 2 7 2e 29 30 2n H 33 34 35 30 37 38 39 40 4142 43 44 45 46 47 48 49 00 6152 WK PM INTERVAL WK PM INTERVAL WK PM INTERVAL OF DATE AGE IN OF DATE AGE IN OF DATE AGE IN YR WKS MILLI-SECS YR WKS MILLI-SECS YR WKS WLLt-SECS i /N2 '/6 952 19 6,- 7 W 2S'7 37 PACEMAKER INFORMATION 2 20 y/g 95 257 38 Type of Pacemaker: Fixed Rate 3 h/(p 73 2S;p. 28 S-DI 9b 259 39 w, m sm, um 4 22 SWP 97 959 40 5 /-30 90 Pfa2 23 ro-Y 92 R5t7 41 Oate of implant-7-14-70 6 J-G 9/ RSJ2 24 (o-// 99 h/ 42 Rate et implant: 72 7 D_-fQa &SD 25 6-/R /OD 2(of 43 8 4WO 83 8 562 26 (M;' /o/ F63 44 ca Upper left chest 9 897 FM R5'a 27 79 /02 263 45 c, er' 10 3-5 55 852 28 79 fo3 %3 46 Number of Pecomekers, il 3-/42 B(c, 153 29 7-/6 /Oy 863 47 including Present: 2 12 349 87 85'8 30 7d7 /d5R(af 48 Underlying Rhythm, CHB l3 3-Ob 28 85Y 31 780 /Ch S&Y 49 14 t'-;7 F5W 32 FM /o7 R6S' 50 D " 8'## 15 e/-9 9p_fg6 33 & /3 /OR 27C 51 Rate at First Cell:_ 71.2 16 e/-/6 9/ P56 34 52 i7 VsG 92 25(o 35 18 PMPC 93 857 36

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