ML20133P488

Human Clinical Protocol for Coratomic C-101 Radioisotope Powered Cardiac Pacer

ML20133P488
Person / Time
Site:	07001342
Issue date:	11/01/1975
From:	BIOCONTROL TECHNOLOGY, INC. (FORMERLY CORATOMIC
To:
Shared Package
ML20133P439	List: ML20133P436 ML20133P445 ML20133P449 ML20133P452 ML20133P458 ML20133P464 ML20133P468 ML20133P476 ML20133P480 ML20133P488 ML20133P497 ML20133P513 ML20133P528 ML20133P532 ML20133P543 ML20133P559 ML20133P562
References
PROC-751101, NUDOCS 8511010030
Download: ML20133P488 (16)

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Page 47 (Attachment 4) 1 i

HUMAN CLINICAL PROTOCOL 1

for

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1 THE CORATOMIC C-101 i

RADI0 ISOTOPE POWERED CARDIAC PACER

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Page 48 (Attachment 4)

TABLE OF CONTENTS

,m-nh SUBJECT PAGE

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1. Investigationci Program Purposa

.1

2. Description of the Pacer and Radionuclide Power Source

.1

3. Patient Selection 1, 2

4. Implantation Tima Period

.2

5. Fciluw-up and Reporting

...........2

6. Patient Control Group

....2

7. Implantation Procedures and Leads

.2

8. Stimulation Threshold Measurements

.2

9. Sensing Threshold Measurements.

... 2

10. Registration and implant Reports

.3

11. Follow-up Data

...3

12. Data and Reports of Removal and Replacement

..3

13. Notification of Deaths, Adverse Reactions or Malfunctions

.3

14. Notification of Loss of Patient Contact

.3

15. Information To and Con:ent From the Patient 3, 4

16. Record Retention

....4 Exhibit I

- References

........5 Exhibit II

- Registration and implantation Data Form

.6 Exhibit ll1 - Follow Up Data Form

..7 Exhibit IV - Pacer Fai!are and Removal or Patient Daath Form.

............... 8 Exhibit V -Informed Consent for Surgicalimplantation of Radioisotope Powered Cardiac Pacer

...9

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Exhibit VI - Patient identification Cards 10 Exhibit Vil - Danor Cards for Adu!ts..

11 Exhibit Vill - Danor Cards for Minors.

12 Exhibit IX -Instructions for Hospital or Clinic Telephone Operators 13 Exhibit X - Suggested Application Format For Nuclear Powered Pacemakers 14 l

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Page 49 COR ATOMIC C 101 (Attachment 4)

RADIOlSOTOPE CARDIAC PACER PROTOCOL November 1,1975 S

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1. Investigational Program of a 20 year life. The pacers have undergone The purpose of the Coratomic C-101 extensive testing for efficacy, including ex-Investigational Program is to obtain statisti.

cessive mechanical shock, impact, and vibra-cal data under controlled conditions to tion testing, and the nuclear fuel is con-determine the reliability, efficacy and lon.

tained in such a manner to prevent fuel gevity of the C-101 Pacer its objective is release under any credible accident, includ-also to provide greater increased longevity ing building or auto accident, fire, fall from compared to standard pacers and prolonged an airplane, crushing, corrosion in sea water, relief from consequences of symptomatic or accidental cremation.

bradycardia for those patients receiving the Data concerning radiation level, safety, C-101 Pacer.

and efficacy testing is on file with the United States Nuclear Regulatory Commis.

2. Description of the Pacer and Radionuclide sion, as a Master Protocol.

Power Source The Coratomic Pacer has been used in The totally implanted, battery powersd dogs since September 1973, and animal cardiac pacer has been in clinical use since testing to assure higher reliability is continu-1960, and is now the selected method of ing as part of Coratomic's data gathering and t

treatment for heart block and other forms of licensing program.

symptomatic bradycardia. it is also used in selected cases of symptomatic tachyarrhyth-

3. Patient Selection mias. An extensive literature has arisen in connection with cardiac pacing, and selected The patients to be selected for this clinical study will be those who have heart block or h s ci n res on ible for th s stu y is cogni ther forms of symptomatic bradycardia re-zant of these and other relevant references, quiring an impianted pacer. The phys,c,an ii and has had extensive experience in the use will select patients who have a life expect-of cardiac pacers, ancy of at least ten

• and preferably twenty years, in order to obtain a maximum amount The C-101 Pacer is an R-wave hibited in of data concerning longevity and reliability demand pacer with a projected life of greater of the unit. An influential factor, however, than 20 years. It is electronically similar to i

other than longevity is that the small size demand pacers which have been in use for and weight of the Coratomic unit may many years. The Pacer provides a nominal enhance the longevity of the patient com-72 beat per minute pulse rate when the pared to other pacemakers, and data on all patient's R-wave is not sensed, and is inhib' ege groups will, therefore, be of value since sted when the R wave,s sensed. The unit is i

additional variables other than life expect-hermetical 1y sealed and shicided against elec-ancy a,e important in the C 101 test. For tromagnetic interference. It has an asynchro-example, the smaller size and weight of the nous " magnet rate" of 90 beats per minute, unit may be statistically significant in reduc-used to ascertai.i cardiac capture and for ing pressure necrosis, lead failure or other operat,onal verificau;n, and will switch to i

volume and shape induced failures unknown the same fixed rate rather than becoming at this time. For this reason, life expectancy inhibited if high energy electromagnetic alone, although still significant, is not as fields are present.

dominant a factor as in the use of other The fuel used for the C-101 Pacer is nuclear pacemakers heretofore licensed for plutonium-238 in its oxide form, pressed clinical applications, and patients with a life l

and sintered into a hard, ceramic pellet. The expectancy less than 20 years should form isotopic battery has been so designed that part of the statistical sample. In certain i h excess electrical power is available at the end cases, also, the physician may judge the use

%d

'The 1971 Life Insurance Fact Dook Institute of Life insurance New York, N.Y.. Page 107, indica'es that in the u.S. total population j

the hfe espectancy of a 72 year old is 10.27 years.

I

Page 50 (Attachment 4) of the C-101 to be paramount in prolonging G. Patient Control Group life in an older patient who has had many A reference control group, identified as previous operations, or is resistant to fre-closely as possible in age, sex, stability and quent operations, or is not mentally capable diagnosis will be used. An attempt should be of handling a rechargeable unit. In these made to include in this group pacer systems V

cases, expected to be a small percentage, th-using lithium or rechargeable nickel cad-physician may use his discretion in implant-mium batteries to provide comparctive data ing the C 101.

on other potentially long lived systems. The From a statistical point of view only, it number of patients in this group should be would be ideal if the distribution of patients equal to the C-101 group. All data and with C-101 Pacers were weighted in the same information collected from this group will manner as the general pacer population, thus be identical to that obtained with the C-101 providing the most accurate statistical data Pacer. All patients in the control group will where the greater number of patients with have unipolar electrodes and have R-wave i

pacers exist. An attempt will be made to inhibited electronics powered by conven-skew the total pacer population in this tional sources currently available.

i manner by continued feedback and commu-nication between individual physicians, and

7. Implantation Procedures and Leads the statistical correlation center at Conventional methods of pacemaker in-Coratomic.

sertion are to be used, ensuring as far as Patients whose life expectancies are lim-possible that the electrodes and leads used ited to less than 10 years by reason of have an expected life comparable to the co-existing diseases will, except for condi-pacemaker and that they have appropriate tions of extreme need, be excluded from this pacing thresholds, in patients with an exist-study. Cooperative and reliable patients, ing leau, the type of existing electrode must who are stab!c and non mobile members of be compatible. If not, standard adaptors the community will be selected to assure may be ussd. Spliced leads may not be used.

accurate long-term follow-up reporting and ideally, Coratomic leads should be utilized study.

to assure long-term compatibility with the pacer materials. Myocardial or endocardial leads may be used with any of the standard

4. Implantation Time Period surgical approaches for lead implantation in The clinical implantation period discussed either the lef t or the right ventricle. The in this protocol will continue for two years, C-101 pulse generator may be impianted in at which time this study will have completed the subcutaneous tissue of the abdomen, its implantation period. All patients will be chest wall, the subpectoral muscular tissue monitored until the death of the patient or of the chest *.,all, or any other area deemed removal of the oacer.

suitabic by the responsible physician.

8. Stir.slation T..reshold Measurements

5. Follow-Up and Reporting The pacing threshold wil! be tested for all A care lul follow up and reporting proce-electrodes, old or new, utilizing a battery dure will be followed during the life of the operated, calibrated ( 5% accuracy) pulse patient or until the pacer is removed. At generator with an adjustable amplitude and each examination period an electrocardio-of a pulse duration of.8 to 1.2 milliseconds.

gram will be obtained, with and without the application of a magnet to induce fixed rate Only those electrodes may be utilized in which a threshold is demonstrated no greater operation of the pacer. The following exami-nation in time afiar implant will be fnliowed than 1.5 rr.a if newly implanted or 4.0 ma if chronically implanted, whether transvenous as closely as possible: 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />,1 wcek,1 rnnth, 3 month and 6 month, tervals, or epicardial, measured at a pulse width of m

1.0 milliseconds.

tarcafter, until removal. Telephone trans-mission and testing of pulse intervals can be l

used to supplement the regulm in office D. Sensing Measurements examination schedule. It is recognized that if possible, the amplitude and width of general medical care may be more frequent the patients ORS wave should be measured.

than this, but this is the minimal time Measurement should be between a ground between tests of pacer function by the study plate in the pacer subcutaneous pocket and clinic, or responsible physician.

the lead terminal distal to the heart.

Page 51 (Attachment 4)

10. Registration and Implant Reports form, Exhibit 11, will cttempt to pursue the immediately upon implantation of the patient until a satisfactory explanation or C-101, the physician or hospital will com-terminus of the lost pacer case is provided.

plete a Registration and Implant Data Form, and forward it, withia 10 days, to the

15. Information To and Consent From the Coratomic Data Center. The form includes Patient identification of the pacemaker, the pa-

a. All patients will be completely informed tient, the physician, the hospital, and heart about the nature of the clinical trial by lead, and adapter (if used), stimulated rate, the investigator, and to confirm this com-and clinical data concerning the patient and munication, will sign the informed con-his or her cardiac disease. The data form is sent form (Exhibit V). They will be shown as Exhibit II, attached, informed of alternative procedures.

11. Fcilow-up Data

b. All patients accepting the pacemaker must agree to the follow up scheme summa-The follow up data, reported at intervals ah and to me remmal and mum as discussed in 5 above' " Follow-up and physician (and from them to Reporting", will be prepared by the investi-Coratomic) of the unit upon the comple-

~

gator and submitted to the Coratomic Data tion of its expected useful life (20 years),

Center on the Follow-up Data Form. This its failure, or upon the patients death, form is attached, (Exhibit 111) and provides whichever occurs first. A legally binding information on the patient, C-101 Pacer document (Exhibit V) w,ll be signed by i

function and a brief clinical history of the the patient, a witness, his spouse, and/or a patient including laboratory data, adverse ret tive of the patient.

reactions to the implanted device, if any, a description of the reactions and opinions as

c. The patient will be required to carry. an to the nature and major cause of the identification card as stated in the form reactions, and an evaluation of the efficacy shown in Exhibit V. This card is shown in of the device and procedure.

Exhibit VI. The card will identify the p

carrier as a radioisotope powered cardiac

12. Data and Reports of Removal and pacer patient, will specify the manufac-V Replacement turer and model number of the subjects p cemaker, specify the radionuclides con-Removal and Replacement constitutes tained in the pacer, and present explicit particularly significant data, and therefore, a cadon of msponsg ns rn special form, " Pacer Failure and Removal or p rties in the event of accident or diffi-Patient Death", is provided, Exhibit IV. This culty. The patient will also be required to form has all pertinent recuired data concern-ing the patient, investigator, hospital, and cany a unpun anammkal M M N, as shown in Exhibit Vll. If the patient has reasons for removal and replacement includ-n a

n aMy age, & agem ing whether the failure was of battery, card shown in Exhibit Vill should be electronic, or lead origin. Corrective proce-executed by the patient where possible dures and results of patient examinations are and his or her legal guardian.

also required.

d. The patient will also be required to carry

13. Notification of Deaths, Adverse Reactions or an identification bracelet of the medical-Malfunctions alert type which will carry the same Notification of death is included in the patient's name and a statement to call the form, " Pacer Failure and Removal or Patient pr per emergency telephone and phys,-i Death", shown in Exhibit IV. The cause of cian in emergency. This bracelet is men-t,oned in Exhibits lil and IV.

r death and autopsy findings are included.

c. The patient will participate in follow-up

14. Notification of Loss of Patient Contact examinations as discussed in 5 above, and he will be required to agree to do so on Th.is notification.

included.

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the informed consent form of Exhibit V.

y1 Follow-up Data Form, Exhibit lil. The reasons for loss of contact and steps taken to

f. The patient will notify the hospital of any reestablish contact are included. If loss of change in address or contact and will be contact is reported on this form, Coratomic, required to agree to do so on the in-with data provided in the initial implant formed consent form of Exhibit V.

i

Page 52 (Attachment 4)

9. The patient will be required to notify the

16. Record Ret:ntion hospital of his intention to travel in foreign countries. The hospital will, in All pacer records will be maintained sepa-turn, notify Coratomic, who will notify r tely from the routine hospital records, p

the Nuclese Regulatory Commission. The either by a centralized authority so desig-d patient agrees to provide thisinformation nated, health physics personnel, or the pace-on the informed consent form (Exhibit m ker clinic within the hospital's jurisdic-tion, or the physician responsible for the V),

study.

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EXHIBIT I (Attachment 4)

REFERENCES

1. Smyth, Nicholas P. D.: Cardiac Pacemaking. SurgicalDiseases of the Chest, Second Edition in Press, Editor Brian Blades., C. V. Mosby Co., St. Louis, Mo.,1974.

2. Chardack, William M.: Cardiac Pacemakers and Heart Block. In Surgery of the Chest (Chapter 38),

Second Edition, Editors John H. Gibson, Jr., David C. Sabiston and Frank C. Spencer. W. B.

Saunders Co., Philadelphia, Pa.,1969.

3. Furman, Seymour, and Escher, Doris J. W. : Principles and Techniques of Cardiac Pacing. Harper and Row, New York, N.Y.,1970.

4. Thalen, Hilbert J.: The Arti//cial Cardiac Pacemaker: Its History, Development and Clinical Application. C. C. Thomas, Springfield, Ill.,1969.

5. Hurzeler, Philip; Decaprio, Vincent; and Furman, Seymour, Montefiore Hospital and Medical Center, New York, N.Y.: Endocardial Electrograms and Pacer Sensing; paper presented at AAMI 10th Annual meeting March 17-18,1975.

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EXHlBIT ll Page 54 REGISTRATION AND IMPLANTATION DATA FORM CORATOMIC C-100 SERIES ISOTOPIC PULSE GENER ATOR s

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1. Par ent Name c..,

$ c:a! Security No Hosp.ta. Record N)

Home Address C.ty State Zip A C & Phone Business AdJress C tv 9 ate Zp-A.C & Phone Name, address, a,J telephone of persents) to be contacteJ +1 pat ent cannet be accated C ty State Z.a A C & Phone Relat>or' ship to Pat ent Name, add ess. a,J temansae of aite' rate persor@ to be contacted if pat cet cannot be loca:e3 Cay State 20 A C & Phone Re'adocship to Pat.ent

2. Phys:cianN and Hascital f.ame Off.ce Address C.tv State Zip A C & Phone 3 Rad.3. sot 0pe P *e ed Pacer Inf arrration 3

$eal N3 Dater of it sa :t P aceme,t subcutarecus'sb*uscularlictramscWar other r ;* t te*t pect3r4: abdO-" mal. w the r e n.s! ") *e6 pack et Stamdat. ort rate w t'1 %*aytet wc thout ThreshG'd measse*e*ts b ait d;e Cu rent -

r Pdse Wid'h other method Idesc?'tel Ecs ament ud to measse th eeo'd 4 Pre. ous irraiant f r'ormat'cw T Yes No M ves

%*aas'acturer MMet D a uf ri s.pt WS, removed 70*atNebe' of ;'ev.oas mp a-ts

5. Leas van'act urer P.bdei No.

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.em used Pre.-ous leads lo app cab e ar 1 a.asab

• 1,0ca d a' Number, mo@s ar d milant c4*es how many et moved r Endward ai Neber. modet aad irap ant dves how man y removed' 6 Chmeat data Pat ect's ace Ses Race Heft Wegat R,ght r ard?J s Lef t hande >J Et-ology of a*r%?? m a K.n1 of arrhr"rma Prevoss crug therapy for arrhytwa Atsocisted diseases Temporary pacq f for imt a! #mptants onf yl L_ Yes iNJ Anest*etics used during surgery Ant bot cs locally syste n ca'ly w ne o

Cortesones or other arti infiamatory drugs locatt r's ystem.c ally /none Was pocket dra ned. C Yes C No if yes. Fow loeg' g

D.d compf 6cateors or adverse reaction occur en: pacemah er lead sorgery lf yes, treatment Comments G

EXHIBIT 111 Page 55 (Attachment 4)

FOLLOW UP DATA FORM COR ATOMIC C 100 SERIES ISOTOPIC PULSE GENER ATOR Please complete tMs form. Retain one copy con ATOM lC. iNCORPOn AT E O for your records and return one copy ro:

OATA Er En p

Indiana. Pennsvivansa 15701

1. Patient Nar-e Last First snatial Social Secur;ty No.

Patient Hospital Record No.

Pulse Generator Serial No.

Date of frrplantation Date of Follow up Name of Ph/sician Name of Hospital Telephone No.

Address City State Zip Patient has I.D. Card:

Yes No Patient is wearing Bracelet er its Equ; valent:

Yes No C 100 Series Pacer Information Sat;sfactory Unsatafactory Stimulation Rate -with Magnet without Mag.et Descript.ca of adverse react.ons Nature and cause of adverse reac* ion

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U Desenption of side effects Toxicity Contrain+ cations inef fectiveness Pacer malfunction Pacer degradation Has any repair, relocation c' replacement of leads been necessary?

Yes No

3. Has satisfactory contact been maintained with the patient for follow-up and accountability purposes? Yes No if no, why was contact lost ?

What steps have been taken to re establish contact ?

i

. Summary of medical examination, including laboratory data (at yearly intervals)

EXHIBIT IV Page 56 (Attachment 4)

PACER FAILURE AND REMOVAL OR PATIENT DEATH FORM COR ATOMIC C-100 SERIES ISOTOPIC PULSE GENER ATOR f'%

Please complete tks form. Retain one copy COR ATOMIC. 4NCORPOR ATE D for your records end return one copy to:

DATA CE ER Indiana, Pannsvivania 157o1

1. Patient Name 4

Last F orst initial Social Security No.

Patient Hospital Record No.

Pulse Generator Serial No.

Date of implantation Date of Follow-up Name of Physician Name of Hospital Telephone No.

Address City 9 ate Zip t

Patient has I.D. Card:

Yes No Patient is wearint, Bracelet or its Equivalent:

Yes No

2. Pacer Failure Battery Failure Lead Failure Electronics Failure Description of Failure Corrective Procedure Due to Failure D

Replaced Pacer Model and Serial Number of Rep!acement Rep! aced Lead Model and Serial Number of Rectacement Lead

3. Patient Death Causes of Death Autopsy Findings Was Pacer functioning at time of death? Yes No Was Lead functioning at time of death? Yes No

4. Summary of Medical Ewaminations (if other than death)

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EXHIGlT V (Attachment 4)

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INFORMED CONSENT FOR SURGICAL IMPLANTATION

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OF R ADIOlSOTOPE POWERED CARDIAC PACER COR ATOMIC C-100 SERIES ISOTOPIC PULSE GENER ATOR I understand that for the treatment of my cardiac condition - a disturbance of normal cardiac conduction - a cardiac pacer is to be implanted in me. I unders'and that the surgical procedure mayhvill require the implantation of a new electrode or lead into or onto the surface of my heart. While the surgical procedure is not of unreasonable risk, the possibility of complications or even death exist, The procedure has been explained to me, and I have had the opportunity to ask any questions concerning it.

I understand that the paccr to be usad for the implantation is a radioisotope powered cardiac pacer manufJCluted by Coratomic.

The pacer is now undergoing its initial clinical usa. Although the pacer has been extensively tested, it is of relatively new design, and there is no assurance that its components will last the full design life. On the basis of experiments in animals and in the laboratory, units of this type are expected to have a reliable life expectancy in excess of that of current standard cardiac pacers. I understand that the cardiac pacer does produce radiation, but i have been told by my attending phyucian that it is his medical judgment that j

this radiation presents a neg!igble hazard.

I understand that in consenting to the imp!antJtion of this pacer, l am authCriling, as well, all stJndard operating procedures, including 15 administra :on of anesthetics vshich may be incident to the operation. For the purpose of advancmg med. cal and f

scientific ecMed;c,I consent to the admittance of observers to the operating room.

i Since the dcvice contains radioisotope material (Plutonium 238), ultimately, af ter my death or earlicr, if the useful hfe of the pacer is exceeded, if at aases to function ef fectivc!y for my medical needs, or if I requot to have it removed, the pacer must be returned to Coratomic via (licensed institutioni. Accordingly, I agree to contact (institution) at regular intervals of no less than six months, and whenever I change my residence. I will always carry the appropriate indentification card on my person, and will at all times wear the standard ident'fication t racctet.

Notwithstandmg m/ contacting the implanting ir,stitution foHowing the insertion of a cardiac pacer of any sort, I am advised to remain in contact with m / personal physician.

I agree to notify the hospital, who will, in turn, notify Coratomic of my intention to travel in foreign countries. Coratomic will, in turn, notify the Nuclear Regulatory Commission.

I understand that the radicisotope powered cardi 3C pacer is a highly techn: cal prosthetic device and in order to assess the effectiveness ofits use (institution) and Coratomic are interested in collectmg data upon the device. According!v, I agree to examination by my physician at no less than the following intervals; at 1 month,3 months and C month intervals, thereaf ter, following the insertion of the pacer. I further agree to provide information on my chnical condition as it pertains to the pacer at no less than G mcnth intervals. Furthermore, I consent to disc!asure by the chnic or Coratomic of any information acquired by the chnic in regard to the implantation of the radicisotope powered cardiac pJ.er, provided, however,in r'o event shall d:sclosure other than to Coratomic include my identificatron without my specific written approval.

l have had the opportunity to aW questions pertainmg to the surgical procedure, the radioisotope powered cardiac pacer, and I

the follow up procedure. The possibfe alternate methods of treatment, including the use of conventional chemical battery powered pacers ar d rechargeable pacers. hue ben caHed to my att?ntion.

With these f acts in mind and inNnding to be lega!!y bound, I hereby authonte the surgical procedure whereby the Coratomic radioisotope powered pacer w:ll be implanted in me wamng the right to claim that such procedure was not properly authorized, j

and I agree to the follow-up procedures and to the of timate return of the unit as detailed at;ove.

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Patient's scature or persort authorsted to coment fo* the (Oatel j

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f Relationstup to the panent signing if other than the patient.

i P'*aw sgn 3 cop'es I certify that I have emp!ained the above procedure i

i t copy to patient i

t copy to hospital Dr.

IDatel 1 copy to Coratomic 1

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EXHIBIT VI Page 58 (Attachment 4)

PATIENT IDENTIFICATION CARDS CORATOMIC C-100 SERIES ISOTOPlc PULSE GENERATORS O

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EXHIBIT Vill Page 60 (Attachment 4)

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Page 61

]

EXHIBIT IX (Attachment 4)

INSTRUCTIONS FOR HOSPITAL OR CLINIC TELEPHONE OPER ATORS COR ATOMIC C-100 SERIES ISOTOPIC PULSE GENER ATOR v

Project Nuclear Pacemaker instructions to Operator;

1. Accept any collect call with reference to " Project Nuclear Pacemaker".

2. Any call concerning " Project Nuclear Pacemaker" involves a patient with a nuc! ear pacer and requires immediate action to insure that there is no danger of radiation exposure and recovery of the nuclear pacer.

3. Obtain as much information from the caller as is possible including:

Caller's Name and Where he may be Reached.

Patient's Name, Status, and Where he may be Reached.

At:ending Physician (if any) and %here he ma, be Reached.

Information from Patient I.D. Card Patient's Social Security No.

Date of implant Pacer Serial Number

4. Notif y immediately:

(Name, a%ess, telephore number of physician responsibfe for study)

If he cannot be reached, not.fy:

Name, address, tetephone number of atternstrve physician.

If neither can be reached, contact physician on duty for the Cardiac Care Unit; inform him that this involves a nuclear pacer; and advise him of the information you have and the urgenet of the matter.

\\

s

Page 62 EXHIBIT X (Attachment 4)

SUGGESTED APPLICATION FORMAT FOR NUCLEAR POWERED PACEMAKERS CORATOMIC C 101 ISOTOPIC PULSE GENER ATOR Chief, Matenals Branch Division of Fuel Cycle and Materials Safety JU. S. Nuclear Regulatory Commission Washington, D. C. 20553 Re: Application for license to participate in the research study involving the emplantation al Coratomrc C 101 nuclear powered pacemakers. Each containing 250 mdhgrams of Pu 233 K 4 3 curies)

Gentlemen:

The following information is submitted :n apphcation for a license to participJte in the investigational program utilizing the Coratomic C 101 nucicar powered pacer.

1. ApphCa*11:

tHepital or rJcSca Iris titu tion)

MdJresO IState and La Code)

2. Physicians responsib!e for study: (Pronde this information for EACH physician on the study teaml Name.

Office Address:

Telephone Number:

State Licen'ed in Which to Practice; Specialty Board Certification:

Position with the Appbcant:

Previous eveerience m the chmcal impfantation and rohow up of pacemakers by physicians.

(:nclude dJration of pacemaker experience, total number of implant physician has done, and the total numt,er he has done at the app!; cant's facihhes.)

3. Protocol to be followed:

O HUMAN CLINICAL PROTOCOL FOR THE CORATOMIC C.101 RADIOlSOTOPE POWERED CARDIAC PACERS DAT NOVEMBER 1,1975.

4. A maximum of Corat:,mic C 101 pacemakers is rusted to he implanted annually during the study.

5. Desenption of physical fadhties and equipment at the app:icrit irntitution or to:pital-(In;tude description of card JC cPc unit and curatmg fauhhes.M hst wecif c causpment needd and uttAle to carry out the stud /, metode ecmprent for measuring st"nulation threshWds, thresholrf parameters, and ove90 nao:m.9er f McDon).

6. Description of acphcanti 'rtfr1t pacemner implantation and foHow up program: (loclude site, te, nJmtWr of DJt ents, Jnd duration.)

7. De:crite methods applicant m!! ; 9 hsh to maintain records of implantation and fu! Ion up of p3tients separato from routine hospital records. (include procedara :

w.uring continuit/ of foHow=up and determining any pmbre loss of fnHow up Wh a p 3tien t).

8 Confirm that the appheant instituticn or hospd will establish a;;propriate centrol procedures to msure the physical utcurity of the pacemaker while in the possessio's of the appMant. These procedures will include keeping track, by serial numtwr, of the location of each pacem ker and requiring that thJy '.3 kept under lock and key when not bem] up'd to quard a'pmtt loss or a

thef t. Confirm that a!! activities wdl be conducted in accordance with the regulations urider Title 10, Coda of Federal Regulations, Pari 70.

0. Describe the applicants procedures to assure notification of appropriate individuals upon receipt of an cmerqency report of inquiry concermn1 a pacemaker I/arer, include veritten instructions to be given to talephone operaturs.

10. Confirm that the rhysicians responsit,10 for and psrticipating h the stud / represent that they are famihar with CorJtomic C-101 Protocol and the Coratomic C.101 Pacer and understand that the issuance of a hcense is r.onditional upon the following of this

protocol,

11. Confirm that the appheant institution agrees to continue the follow up reportmg and reenvery procerfurcs during the hfe of the patient and until the pacemaker is recovered and returned to Coratomic, Inc., P.O. Hox 434, Indiana, Pa.15701, even in the event the phvsiciant riamed in the app!ication to participate in the study are no longer assodated with the appbc tnt.

12. Confirm that pickagmg, labehng, and shipping instructions to t>e furnished by Coratomac, Inc. will te foHowed upon the retturn g of the pacernaker for approved disposal.

.3, The applicant hospital or nvdical institution heretty rettisetts.s Ocstn.e to receive, possess, store, and implant the Coratomic C 101 nuclear powered paccinab er in accordance with this apphcation.

Sgrud: Applicant:

By:

Physicians responsible for study:

n...... -, aa u....a em, %,..a........

_ _. -.. -__ -.- _.. = _. _

Page 63 (Attachment 5) 4 I

O 4

i l

j liUMNi IMPLANTATION PROTOCOL l

FOR I

t TiiE CORATOMIC C-101-P RADI0 ISOTOPE POWERED CARDIAC PACER i

!O i

March 2, 1983 l

l l

l l

1 i

Caratomic Wl l

P, O. DOX 434, IN0lA NA PCNNSYLVANIA 15F01 r.'. \\

I PHONE (412) 3491811 TELEX 48 8668

, /

f J'

,\\

)

f(

+

u

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--v.--..------,-.-v.-v_

-_w-,-,..-,--.,,,-y-,-_-,m.,_._,,,

,yy y__,m

.,_,f

=_3 Page 64 (Attachment 5) l' TABLE OF CONTENTS SUBJECT 1.

Description of the Pacer and Radionuclido Power Source 1

^

2.

Patient Selection.

2 f

1 l

3.

Follow-up and Reporting.

2 l

4 4.

Implantation Procedures and Leads.

2 l

l 5.

Stimulation Threshold Measurements 2

6.

Sensing Threshold Measurements 3

l 1

)

7.

Registration and Implant Reports 3

l l

j 8.

Follow-up Data 3

)

j 9.

Reports of Removal and Replacement 3

1 j

10.

Notification of Deaths, Adverso Reactions or l

l Malfunctions.

3

{

i I

11.

Notification of Loss of Patient Contact.

4 12.

Information To and Consent From the Patient.

4 O

13.

Rocbrd Rotention.

5 j

i j

14.

Accountability and Recovery.

5 References 7

i Exhibit I Exhibit II

- Registration and Implantation Data Form.

8 Exhibit III

- Follow-up Data Form.

9 Exhibit IV

- Pacer Failuro and Removal or Pationt Doath Form.

10 l

Exhibit V

- Informed Consent for Surgical Implantation l

of Radioisotopo Poworod Cardiac Pacer 11

}

t l

Exhibit VI

- Patient Identification Cards..

12 i

Exhibit VII

- Donor Cards for Adultu 13 i

t Donor Cards for Minorn 14 l

i Exhibit VIII Exhibit IX

- Suggonted Application Format for Nuclear Poworod Pacomakorn.

15 O

Exhibit X

- Instructionn for llospital or Clinic I

Tolophono Oporators.

16 j

l i

t r

t

m..

Page 65 (Attachment 5) 1 l

I CORATOMIC C-101-P i ()

RADIOISOTOPE CARDIAC PACER PROTOCOL f

t l

March 2, 1983 1

1.

Description of the Pacor and Radionuclide Power Source I

An extensive literature has arisen in connection with l

j cardiac pacing, and selected references are listed in 4

Exhibit 1.

The physician responsible for pacer implantation I

is cognizant of those and other relevant references and I

has had extensive experience in the use of cardiac pacers.

i The C-101-p pacer utilizes a programmable hybrid j

circuit, the pacing modos and operating paramotors of which can be noninvasively changed using a coratomic hand-held programmer.

It is electronically similar to

[

1 programmable pacers which have boon in use for many years, i

j While the unit is normally used as an R-wave inhibited t

i (VVI) pacemaker, the implanting physician may elect to

(

j use the pacer for asynchronous (VOO) pacing when appro-priato indications are present.

• he pacing rato is programmablo at 13 sottings ranging from 38 to 120 PPM.

Pulso current can be not l

()

to either 4 or 10 mA.

Sensitivity is programmable to l

1.5, 2.5, 4, or 5 mv.

The pacer can be changed from its l

normal R-wave inhibited (VVI) modo to asynchronous (VOO) i pacing by placing the sensitivity selector to its FR l

(Fixed Rato) sotting, j

l The unit 13 hermetically scaled and shioided against j

clectromagnetic interforence.

It has an asynchronous

" magnet rato", identical to the programmad pacing rato, used to accortain cardiac capture and for operational verification.

If high energy oloctromagnetic fields aro

[

prosent, the pacer will owitch to a fixed rato rather than becoming inhibited.

i l

Tho fuel unod for the C-101-p is plutonium-238 in l

its oxido form, prossed and nintored into a hard, ceramic j

pollot.

The isotopic battery han boon no designed that i

1 excess cloctrical power is availablo at the and of a

(

40 year lifo.

The pacers havo undergono extensivo testing

[

for of ficacy, including exconsivo nochanical shock, impact, j

and vibration tonting, and the nuclear fuoi is contained t

in such a mannor to provant fuel roloano under any crediblo accident, including building or auto accident, firo, fall from an airplano, crunhing, corrosion in noa wator, or accidontal cremation.

t l

Data concerning radiation levol, cafoty, and officacy tunting in on filo with tho United Staton Nuclear Regulatory Commission, an a Mantor Protocol.

1

Page 66 (Attachment 5)

I j

2.

Patient Selection Cooperative and reliable patients, who are stable, l

and non-mobile members of the community, will be selected l

l to assure accurate long-term follow-up reporting.

s j

3.

Follow-Up and Reporting The physician or hospital will be required to contact the patient at least ovary six months, and report the contact to Coratomic.

This contact will be maintained

]

during the life of the patient or until the pacer is re-j moved.

"In-person" follow-up visits are proforablo;

}

however, telephone contacts are acceptable.

At the time of follow-up, patients should be reminded of the impor-i tance of carrying their I. D. card and uearing their I.

D.

jewelry.

Any complications or adverse reactions must bc reported to Coratomic by the physician or hospital.

Cor-i 4

j atomic will consolidato the reporting of patients and notify l

the Nuclear Regulatory Commission of the results of its

[

accountability program twice por year.

If the patient's i

4 j

whercabouts are unknown, Coratomic will, through its contacts l

l with the hospitals and physicians, locato the patient and forward this information to the hospitals to provide complete accountability.

ijp 4.

Implantation Proceduros and Leads I ()

Conventional methods of pacemaker insertion are to be

{

used, ensuring as far as possible that the cloctrodes and leads ased have an expected life comparable to the pace-i maker and that they have appropriate pacing thresholds.

In patients with an existing lead, the type of existing i

J olectrode must be compatible.

If not, standard adaptors f

may be used.

Spliced leads may not be used.

Ideally, Coratomic leads should be utilized to assure long-term compatibility with the pacor materials.

Myocardial or andocardial loads may be used with any of th. standard j

surgical approaches for load implantation in oither the j

loft or the right ventriclo.

The C-101-p pulso generator may be implanted in the subcutaneous tissue of the abdo-men, chest wall, the subpoctoral muscio tissuo of the chest l

wall, or any other area doomed suitable by the responsible i

physician.

[

i l

5.

Stimulation Throshold Moauuromonts

\\

l The pacing threshold will be tasted for all olectrodos, l

1 old or now, utilizing a battory-operated, calibrated (15% accuracy) pulso gonorator with an adjustablo amplitudo and of a pulso duration of.8 to 1.2 milliseconds.

i f

only those cloctrodos may be utilized in which a i

threshold is demonstrated no greator than 1.5 mA if newly implanted or 4.0 mA if chronically implanted, whethor j

transvonous or opicardial, monsured at a pulso width of r

! l L

f

Page 67 (Attachment 5) i l

1.0 milliseconds.

()

6.

Sensing Measurements l

I If possible, the amplitude and width of the patient's QRS wave should be measured.

Measurement should be be-i twcon a ground plate in the pacer subcutaneouc pocket and 1

the lead terminal dist?1 to the heart.

i 7.

Registration and Implant Reports Immediately upon implantation of the C-101-P, the

{

physician or hospital will complete a Registration and 1

Implant Data Form, and forward it within 10 days to the Coratomic Data Center.

The form includes identification j

of the pacemaker, the patient, the physician, the hospital, i

the heart lead and adapter (if used), stimulated rate, and clinical data concerning the patient and his or her l

l cardiac disease.

The data form is shown as Exhibit II, attached.

I j

8.

Follow-up Data The follow-up data, reported at six-month intervals, j

will be prepared by the physician or hospital and sub-mitted to the Coratomic Data Center on the Follow-up l

i Data Form (see Cxhibit III, attached).

This form summa-i()

rizon information on the patient and lists any complica-l tions, adverse reactions or pacer malfunction.

"In-porson" l

follow-up visits are preferabic; however, telephonc contacts are acceptablo.

At the time of follow-up, I

patients should be reminded of the importance of carrying their I. D, card and wearing their 1. D.

jewelry.

9.

Reports of Removal and Replacement I

A special form, " Pacer Failuro and Removal or Patient Death," (Exhibit IV) is providad.

This form records all j

portinent required data concerning the patient, physician, hospital and roasonn for pacor removal and replacement, i

including whether the failure was of battery, electronic, or load origin.

Correctivo proceduros and results of patient examinations are also coquired.

i In the ovent of pacer romoval, the pacor must be re-covered and returned to Corntomic.

The hospital and/or l

the physician shall notify Coratomic,and the licensing agency,of the pacor removal, and Coratomic will send tho l

propor shipping container and instructions to the explanting institution for the pacemaker's roturn.

I l

10.

Notif_ication of Donths,_Advorno Ronctionn or Malfunctionn I

i Notification of death is included in the form "Pacor i

Palluro and Removal or patient Death" (Exhibit IV).

Tho couno of death and autopsy findir 's aro includod.

i [

j

Page 68 I

(Attachment 5)

In the event of patient death, the pacer must be re-covered and returned to Coratomic.

The hospital and/or the physician shall notify Coratomic,and the licensing agency, j

of the patient death and pacer removal within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of j

such oacurrence, and Coratomic will send the proper shipping container and instructions to the explanting institution for i

the pacemaker's return.

Coratomic will immediately notify

)

the Nuclear Regulatory Commission of the patient death, f

11.

Notification of Loss of Patient Contact I

L The hospital must notify Coratomic,and the licensing l

agency,within ten days of the loss of contact with a 4

nuclear powered pacemaker patient.

This natification can

(

be made on the Follow-up Data Form, Exhibit III, which l

outlines the reasons for loss of contact and steps taken to reestablish contact.

When loss of contact is reported, Coratomic will immediately notify the Nuclear Regulatory l

Commission and will pursue the patient using data from the initial implant form (Exhibit II) until a satisfactory j'

explanation is obtained.

Coratomic will advice the hospital of their findings.

J 12.

Information To and Consent From the Patient j

a.

All patients accepting the pacemaker must agree to maintain contact with the physician or hospital as i

summarized above and to the removal and return to the physician (and f rom them to Coratomic) of the i

unit upon completion of its expected useful life i

(40 years), its failuro, or upon the patient's death,

]

whichever occurs first.

A legally binding document I

(Exhibit V) will be signed by the patient, a witness, the patient's spouse, and/or a relative of the patient.

i b.

The patient will be required to carry an identifica-l tion card as stated in the form shown in Exhibit V.

This card is shown in Exhibit VI.

The card "ill identify i

the carrier as a radioisotopo poworod cardiac pacer 4

patient, will specify the manufacturer and model number of the patient's pacemaker, specify the radionuclidos contained in the pacer, and present explicit instruc-tions for notification of responsible partion in tho ovent of accident or dif ficulty.

At the timo of #ollow-up, patients should bo reminded of the importa-v of carrying their I. D. card.

The patient will also t

{

be required to carry a uniform anatomical Gif t Act Card, l

as shown in Exhibit VII.

If the patient has not at-tained majority ago, the agroomont card shown in j

Exhibit VIII should bo oxocuted by the pationt whero i

possible and his or har logal guardian, i

c.

The pationt will also be required to carry an idonti-i fication bracolat or other equivalent jewelry of the medical-alort typo which will carry the same patient's namo and a statement to call the propor omorgoney l l

~--

I Page 69 I

1 (Attachment 5) telephone number.

At the time of follow-up, patients should be reminded of the importance of wearing i

their I. D.

jewelry.

This medical alert jewelry j

is mentioned in Exhibits III and IV.

j d.

The patient will maintain contact with the physician i

I or hospital as discussed in 2 above, and he will be l

required to agroo to do so on the informed consent

)

form of Exhibit V.

4 1

i e.

The patient will notify the hospital of any change either i

in his/her address or in the names and addresses of two persons to ba contacted if the patient cannot

+

+

be located.

The patient will be required to agrec to do ao on the informed consent form (Exhibit V).

l j

f.

The patient will be required to notify the hospital of his intention to travel in foreign countries.

l The hospital will in turn notify Coratomic, who will notify the Nuclear Regulatory Commission.

The I

patient agrecs to provido this information on the Informed Consent Form (Exhibit V).

13.

Record Rotention I

All pacer records will be maintained separately from i

j the routino hospital records, either by a contralized j

authority so designated, health physics personnel, or the l

pacemaker clinic within the hospital's jurisdiction, or l

the physician responsible for the implantation program.

I The hospital or the implanting physician will notify L

Coratomic of any change in the patient's address or con-i dition so that Corntomic may maintain curront records on the patient.

Tno patient's chart, both at the hospital and in the physician's offico, mnst prominently indicato that tho l

pacemaker must be returned to Coratomic upon its removal I

from the patient for any reason.

I j

14.

Accountability and Rocovery i

Under a.qpocial nucioar material license issued for implanting radioisotopic pacemakers, the patient's hospital assumes the ronponsibility for the control, accountability and recovery of the special nuclear i

motorials (plutonium) in the pacemaker.

Conditions l

for accountability and recovery include the following:

The hospital shall not receivo or transfor in any a.

single transaction ono gram or moro of plutonium con-O tained in the nuclear-poworod pacomakers without noti-fying tho Division of Safeguards, U. S. Nuclear Hoquia-tory Commission, Washington, DC 20555, and, in addition, completing and distributing Form NRC-741 As required by Section 70.54 of 10 CPR part 70.

t l

Page 70 (Attachment 5) b.

The hospital shall report to Coratomic, Inc. (the manufacturer of the pacemaker), and to the licensing O

agency,within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of occurrence, the death of any nuclear-powered pacemaker patient.

Coratomic will im-mediately advise the Nuclear Regulatory Commission.

c.

The hospital shall report to Coratomic, Inc., and to the licensing agency, within 10 days, the loss of contact with a nuclear-powered pacemaker patient.

Cor-atomic will immediately advise the Nuclear Regulatory Commission.

d.

The implanting hospital should normally be able to follow a patient for life, considering that non-mobile patients are selected and that telephone contacts may be used for follow-up.

In unusual cases where follow-up difficulties are experienced, Coratomic should be con-tacted to try to arrange transfer of responsibility to another hospital.

Responsibility could be transferred to another hospital if:

(1)

The new hospital is properly licensed and agrees in writing to accept full responsibil-ity in accordance with the protocol; (2)

The old hospital transfera responsibility in writing; (3)

The patient signs revised consent forms and receives revised I. D. card and I. D.

jewelry; (4)

The appropriate licensing agencies are notified of the transfer and provided copics of the documentation.

Following a proper transfer, the old hospital may of course amend or terminate its license as appropriate.

l s

camos : a Pa9e 71 (Attachment 5)

REFERENCES

1. Smyth, Nicholas P, D.: Cardiac Pacemaking. Surgical Diseases of the Chest, Second Edition in Press.

Editor Brian Blades., C. V. Mosby Co., St. Louis, Mo.,1974.

2. Chardack, William M.: Cardiac Pacemakers and Heart Block, in Surgery of the Chest (Chapter 38),

Second Edition, Editors John H. Gibson, Jr., David C. Sabiston and Frank C. Spencer. W. B.

Saunders Co., Philadelphia, Pa.,1969.

3. Furman, Seymour, and Escher, Doris J. W.. Princip!cs and Techniques of Cardiac Pacing. Harper and Row, New York, N.Y.,1970.

4. Thaten, Hilbert J.: The Artificial Cardiac Pacemaker: Its History, Development and Clinical Application. C. C. Thomas. Springfield, Ill.,1969.

5. Hurzeter, Philip; Decaprio, Vincent; and Furman, Seymour, Montefiore Hospital and Medical Center, New York, N.Y.: Endocardial Electrograms and Pacer Sensing; paper presented at AAMI 10th Annual meeting March 17-18, 1975.

O 4

e

!'O l

Page 72 (Attachment 5)

EXHIBIT 11 liF0iOW8:

The isotopic

~'

REGISTRAT10f4 AND If1PLAf4TATION DATA FORI1 pacemaker must be recovered CORATOMIC C-100 SERIES IS0 TOPIC PULSE GENERATOR and returned to Coratomic in the event of patient Please complete this form.

CORAT0f11C, INC.

death or pacemaker removal.

Retain one copy for your DATA CEflTER Please contact Coratomic records and return (within P. O. Gox 434 i for proper shipping i

10 days) one copy to:

Indiana, PA 15 701 1_co_nta i ne r.

_ __j (please print or type) 1.

Patient Name Last first initial Saci al Se curi ty fio. __,___ _ ___,,_, _ Hos pi tal Record No.

tur.e Address.__ _

i Casiness Address

_ __ _... _..... _.. g.O >

e M55, ~ address, and t'Elephone of'Ec~r's'ol1[s) to be contacted i f patlent

~

c a n no t b e l o c a te d _........ _. _.......-.

~~ ~ ~' ~ ~

"~~

~

"'~

IAationship to Patient f.ur.e address, and telephone of alternate person (sTiiTF co~nticted ir "~~

patient cannot be located

~ ~ ~ ~

~ ~ " ~ ' ~ ~ ~

ReUtionship to Patient 2.

Phy s i c i a n ( s ) a n d H os p i t a l :- " ~ ~ ~ ~ ~ ~ "" ~ ~ " ~ ~~ ~ ~~ ~~ ~~~~~ ~~"

N r.e -

3.

Kali oi s otcp e Fowe re(Tic e~ Yn't o iiia tToii:

~-

~ ~ ~-~

Serial No.

Date of implant P:acev nt:

s ubcu ta n eo us / s ubic.u s cu l a r/ i n t r amu s cid~a~rWthe r right/lef t pectoral / abdominal /other existing /new pocket Ltimlation rate: with flagnet without Inreshold ceasurements:

voltage current pulse width

~ ~ " ~

'~'

~ ~ ~ '

other method (describe):

E q u i rme n t us e d to treas u re t h re sh oW i li_,,,,",~~_~~~~,~~,~, ~ ~~_,,,, ~, ;,1, 4.

Previous ITpTalit fn~(ormation:

Yes rto Tf yes:

~

flanuf acturer,

_ _ __, flo de l, __ _,,, Da t e o f i mp l a n t _, __ __,,,.,,,,

Wny removed Total number of prev'ioidTmilants 5.

LeN: llanufacturer

~~~lfid13T10.

Serial No. (for new Tc'aifs~oiDy) iift'~kiit'rTcT~~~lfate oT~iTpTilit

~~

" " " " - ~

Placenent: Myocardial:

right/l tran5 thoracic /transtredias ti nal Endocardial:

vein used Previous leads (if applicabic and avalTaWe):

Myocardial: Number, models, and irrplant datest how many removed?

Endocardial: ~71 umber, motels lis(TrnBant dates; how diriy removest (continued next page)

1 Page 73 t

(Attachment 5)

EXHIBIT 11 (cantinued) 6.

uiinical data:

P.itien t 's age Sex Race Height Weignt,__

___, Right handed /Le f t handed E t i ol ogy o f a rrnythmia _ __ _,.,

K i n d o f a r i h y t h m i a Pe evious drug therapy f or arrhythmia Associated diseases fic Tempora ry paci ng ( fo'~i n'i tTaliin@ ants only )~~~ Yes Anesthetics used daring sur gry An tibi oti cs :

locally /systemicil'y/none l

Cortisones or other anti-inflamatory drugs:

locally /systemicallv/none Was pocket drair.ed:

Ycs No If yes, hcw long?

Did couplications or adverse reactions occur in pace.naker/ lead surgery?

I f y e s, t r e a t i.a n t. _ __.._ _ _. - _...._ _ _ _.. _.. _..

-_.___ -~.._

• • • • • "8'8D M-

-4_ ab d

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Page 74 (Attachment 5) i.

l EXHIB1T III

'~1TIPMTATTT:~ tee isotiliic' l

F0LLOW-UP DATA FORM pacemaker must be recovered CORATOMIC C-100 SERIES IS0 TOPIC PULSE GENERATOR and returned to Coratomic l in the event of patient Please complete this fom.

CORAT01110, ItiC.

death or pacemaker removal.

Retain one ccpy for your DATA CEttTER Please contact Coratomic reco ds and return (within P. O. Box 434 for proper shipping 10 days) one copy to:

Indiana, PA 15701 u _ container.

1.

Patient fiame Social Security fio.

______,_ Hos pi tal Record No.

Mcme Address Business Address

- ___..__._.- _ _). g

- -... ~..

~

~~~

fiire, iddress, and telephoTe"o? person (s) to be conia'cted if p'itient cannot be located,_ _ _ __ _ _ _

A/C & Phone,_ _ _

Relationship to Patient Name, address, and teleph'oTiliTY1 ternate person (s) to be contacted i f patient cannot be located._. _

~ ~ ~ ~

~ ~"

Relationship to Patient

~~~

~

2.

Pnysician(s) and Hospital:

Name O

Office Address

~

...".._. -..... T P'~n's'e

~

~

~

~ ~ " ~ ~

- ~ ~ ' - ~ - - - ~ ~ ~ ' ~ ~ ~ ~ ~ ~ ' '

~ jC

~~~~

3.

Radioisotope Poucred Pacer Information:

Serial No.

Date of Implant

~~~

~~

' ' ~ " ' ~

Date of follow-Up Was follow-up an "in-person" ~vl si~tl~r'TcWphone contact?

Was patient reminded of the importance of carrying I. D. card and weari'nf-

1. D. jewelry?

Yes fic Patient has 1. D. card Yes Nn ~-

Yes flo Patient is wearing Bracelet oFTts Equiv'ilent:

C-100 Series Pacer Information: Satisfactory URsitis factory ~~

Stimulation Rate:

with flagnet

~

~ ~ ~

~ ~ ~ ~ ~ ~ ~ ~

~~~

without flagnet List any complications, adverse reactions, or pacerliaTfunction: ~~

_. _. -. ~ -.

. _ =

Has any repair, relocitTon or rep ~1accinelit of ~1eads Feen necessary.r errno---

~

y Pas satisf actory contact been maintained with the patient for follow-up and accountability purposes?

Yes flo if no, why was contact lost?

Wh3t 5teps have been taken to re is~t'11ill'll contactT-7_~_

Z Z~~ Z '.

~

.. - ~.. _

O

Page 75 (Attachment 5)

EXHIBIT IV l IMPORTANT_:

The isotopic l

PACER FAILURE AND REMOVAL pacenuker mast be recovered i OR PATIEt4T DEATH FORM and returned to Coratomic CORAICMIC C-100 SERIES ISOTOPlc PULSE GEttERATOR in the event of patient death or pacemaker renoval. l Please complete this fern.

CORATOMIC, IflC.

Please contact Coratomic Retain one copy for your DATA CEt4TER I for proper shipping l

cecords and return one P. O. Box 434 I

_c_o.n t.a_i.n.e.r

_...J 4

copy to:

Indiana, PA 15701 1.

Patient flame Last fi rs t Initial Social Security fio.

Patient Hospital Record tio.

Pulse Generator SeriIl flo.

, Da te of Implantation __,[,[

~ ~ " -

~

Date of Follow-up

~

~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ " ~ ~ ~ ~ " ~ ~ ~

~~~

~

flame of Physician NaT.e of Hospital.

. Telephone tio.

l

-=

Patient nas I. h. card:

Yes fio

~~~~~~~~

~

Patient is wearing Bracelet or its EquivaTent:

Yes _,

No How was pacemaker disposed of?

2.

Pacer Failure Eattery failure Leaj Failure Electrnnics f ailure Desc iption of Fa1 ure._

?

Correctlye Procedure Due toF'a'ilure

~

i

~~

Replaced Pacer Model and SeriaT~liumber of Replacecent ilodel and Serial Number of Renlacemen t Lead... _...... _ _

3.

Patient Death Causes of Death I

Ec psy F t nd i ng s _

. __ __" _" __..~^~~' "_.'~..~ _~ ~..'.' _~~.'~ ~ ~ ~~'~ ~..~._..

j

-=-

= - - -.

L'as Pacer functioning at tTi~dIit"dWtlIGes

~}lo Was Lead functioning at tinn of death? Yes flo 4

Sunury of Medical Examinations (i f other than deatliT..

.r --

l

)

=

j f

1 4

1 k

i f

l i

l i

1

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e

i Page 76 (Attachment 5)

EXdIDIT V O'

INFORf1ED COLINT fnR SURCICAL If1PL ANTMION v

0F RADIO!50iOPE FO!KRf3 f.Ai!DIAC PACER CORATOMIC C-100 SERIE'.; lbO10PIC PU:SE GENERATOR I understand that for the treatment of my cardiac condition - a disturbance of narnal cardiac conduction - a cardiac pacer is to be implanted in me.

I l

understand that the surgical procedure may/will require the implantation of a new electrode or lead into or onto tne surface of my ' heart. While the surgical i

precedure is not of unreasonable risk, the possibility of complications or even dea th e. Coratomic. Although the paccr h u Lcen extensively tested, there is na assurance that its components will last the full design life. On the basis of past experience, units of this type are expected to have a reliable li fe expectancy in excess of 40 years.

I understand that the cardiac pacer does produce radiation, but that this radia-tion is negligible.

/

Sir.ce the devico contains radioisotope naterial (Plutonium-2E), ultimatelv, af ter ny death or earlier, if the useful li fe of the pacer is exceeded, i f it ceases to. unction eff ectively for my medical needs, or if I request to have it 4

removed, the pacer nust Le returred

+.0 (ora tonic "ia

(

(licensed institutior). Accordingly, I agree ta contact (institution) at least every six months, und whenever 4 change ny residence.

I will always carry the appropriate identi fication card on my person, and will

',(b at all times carry the Uniforn Anatomical Gi f t Act donor card and wear either T

a Tedical alert bracelet or its equivalent.

Nctaithstanding my contacting the impianting institution followirg the insertion of a cardiac pacer of any sort, i am advised to remain in cor. tact with j personal phjsician.

I agree to notify the nospital, who wiii, in turn, notify Coratomic of my intertion to travel in foreign countries.

Cora tonic wi ll, in turn, noti fy the NJclear Regulatory Comission.

! agree to provide the hospital with the nues, addresses, and telephone n c er5 af two persons to be contacted i f I car.not be located.

I alse agree to noti fy tne nMpital of an" Anges in tho names, addresses, or telepnone nucces of the two persons to be contacted.

I agree to tnintain coot ict with ny physician at least every six months f ollweing the insertion of the pacer. fu 'thermore, I consent to disclosure by the c linic or Coratomic of any infoniation acquired by the clinic in regard to the i;? plantation of the radioisotupe powered cardiac pacer, ;)r.v'ded, however, in no event shall disclosure other than to Coratonic inticde ny identification without my specific written approval.

I have had the opportunity to ask qucStions pertaining to the surgical procedure, th: radioisotore powered cardiac ;>acer, and the follow-up procedure.

The pcssible alternate rathods of treatment, including the use of conventionil chemical battery pcwered pacers have been called to ny attention.

Uith these facts in mind and intending to be legally bound, I hereby authorize the surgical procedure whereby the Coratonic radioisotope powered pacer will be implanted in me waiving the right to claim that such procedure

()

was not properly authorized, and I agree to the follow-up procedures and to the V

ultiNte return of the unit as detailed above.

(continued next page)

=

's Li Page 77 g

EXHIBIT V (Attachment 5) j (conti nued) i

" ' WTtiiiss

~" ToiniT Patient's signature or perc.on (ljate) lh authorized to consent for the patient.

Relationship to the patient signing if i

Please sign 3 copics.

Other than the patient 7

1 copy to patient I certi fy that I have explained the 1 copy to hospital above procedure 1 copy to Coratomic

-~

Dr.

~ ~ ~~ ToiteT i

i i

i

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Page 78 (Attachment 5)

EXHIBIT VI PATIENT IDENTIFICATION CARDS O

CORATOMIC C-100 SERIES ISOTOPIC PULSE GENERATORS t

1 (Front)

Caratomic.

:: -- ~ =

~... _

. DL. t h _ _. _ _ _ _.

C ' t, bl.Il Ilt p c~t ncs 5tt NO p.(t. mCCit 11.i.6 %

c... c,

.,s. ~, _. _.

..a.....

1999 Cf6E.0 O

(Back) l

......._........._.o...,......

2.1...! * "J E. T; *. ".A..;':.:.'i",4L..?. ',L*.'

.es. u..

w.-

RADt0 ACTIVE e%FO.

C.f.. G...itCfs-C....,..... e...... co...,

.%. A %VC 6. A P.C..

....c-.,

e......

00.f

• 4 Pus % 9 m.r O

4

(

Page 79 (Attachment 5) h EXHIBIT VII y

3 DONOR CARDS FOR ADULTS

{g CORATOMIC C-100 SERIES PULSE GENERATOR F

b (Front)

L kr M CQratumlC.

W ::.:. :.7.-.- :::.c.:.

=

l DCNOR CARD FOR ADULis t

l

• • Te e ce eies ~.-I os co=ce i

'!?a t :.':!.c;T.','1'.*/J'on. 'o 'o' *,fe'.*?./.*J.

nc%"J'.:.i',',T.Jo '* *ti;{'.*.'!s e, t'.4.'o'"c'. I*I'.*a.'d ?A Of.

O

• W.%s ov-a g e.

o cass aw soo so i..a m e s a c e w*o= w t

a.ev eteto ceca.s os eanis 4.

Catt fut fotLO*.md cec 4=S Ce pasts uc..w uct,n c.,m H

to s*CWitat l

4 (Back) 11C=ta By feet C0'eos aug tat rottowino two witutstgn su rat petst%Ct 08 I ACn Otnte 4.

l.gao* wee ed Deaes

~ ~

t, 5sh%7 Do's C 4, 5e i.e

$rGNED Bf DOH0e wno at Cp 50the smaND,IN Oye Pet $tteC3 74.

~

rnis is a Lloat Docu=tas vwete sat vwitoem amatoancas caer act,its.

taastNtasi Os 1:anetas sawn IN teel IVtN Cf a(CICt 4 Tat Ctarte C8 IF Ctates ($ taassktw1, Pttalt Catt

-e+ -..

880ftFT Ortsatoe Catt C08stleMS a esvCttae PaCamaste

\\

P

I Page 80 (Attachment 5)

EXHIBIT VIII DONOR CARD FOR HINORS CORATOMIC C-100 SERIES ISOTOPIC PULSE GENERATOR (Front)

Afh. Caratomic, W :r.:::. :- ~~.=:.=

OONCR CARO FCR MINORS on

...N,c.,,,,.

.o,oc c.

a/,7U': laJm':U-/.'t/;'t.'a'./.7. Jo y. '.,Nft80= we f.'A','t "

• "l'ia'*J,fa?. ',"!Mi'.','/ e,'". ?!.' J. *' '?

. Oi s p =G or a. omGa%s Q*

es

• 803' TO fast E88tCT 4 i.

ANT NitCED CBGaNS C9 Pa97$

e ONLT !at 80tto.reNG COGahl C8 Patfl h*ts 8t las La0am h. 44'paal &

I3 e.

e.au5a (Back)

StGNf 3 tv fut CoasCs ;aND C8 88 5 Ce age ttCan CUsecta, AND fat fot:CMNG IWQ WifNil$t1 EN IMt Pf t!!NCE CS (A(N CIMas a.*

n c

..a ou c

s.* o;;;;

7 s o. T.i's.Li G.

.e 0' A.RC

.e o-.

c-,

s v.

DONOS.ad GUafttaN aff CP SOUNO antND wan i.e.

?Nis es a tocat poCumeNT UNDtB IMS UNtf0ta. ANafQasA(at OffI aCI. It$.

famtNfaef C8 leanstaa tawl (N feet tytNt QF ACtectNfat Otates et es plafn IS sammeNtert. ftf ait Catt.

D*

~~

I ne e.e.e Can Se.e.

ft e NottFT C*teatos Catt CONCIEN$ A NUCatAt Pa(84&Ett e

Page 81 (Attachment 5)

EXHIBIT IX SUGGESTED APPLICATI0il FORMAT FOR fiUCLEAR POWERED PACEttAKERS CORATOTIIC C-101-P ISOTOPIC PULSE GEtiERATOR Send to:

Material Licensing Branch Or - Agreement State Licensing Agency U. S. Nuclear Regulatory Comission (if appropriate)

Washington, DC 20555 Re: Application for license to participate in the implantation of Coratomic C-101-P nuclear powered pacenakers, each containing 250 milligrams of Pu-233('4.3 curies).

Gentlemen:

The following information is submitted in application for a license to participate in the implantation of Coratomic C-101-P nuclear powered pacers.

4 1.

Applicant:

j (Hospital or fledical Institution)

J (Address)

(State and Zip CodB

~ ~~

O 2.

Pn>>4c4ene resPenei81e ror 4mP>eetetiee Proorem:

cerev4ee t"ie 4erormat4oe for EACH physician involved) fiame :

Office Address:

Telephone fiumber:

State Licensed in Which to Practice:

Specialty Board Certi fication:

Position with the Applicant:

Previous experience in the implantation and follow-up of pacemakers by physician:

(include duration of pacem.aker experience, total number of implants physician has done, and the total number he has done at the applicant's facilities.)

3.

Protocol to be followed:

HUMAtl IMPLA!1TATIO!i PROTOCOL FOR THE CORAT011IC C-101-P PADI0 ISOTOPE POWERED CARDIAC PACER, DATED MARCH 2,1983.

4.

A maximum of Coratomic C-101-P pacemakers is requested to be implanted annually.

l 5.

Description of physical facilities and equipment at the applicant institution or hospital:

(Include description of cardiac care unit and operating facilities and h

list specific equipment needed and available for the implantation d

program; include equipment for measuring stimulation thresholds, threshold parameters, and overall pacemaker function.)

6.

Description of applicant's present pacemaker implantation and follow-up j

program:

(Include size, i.

e., number of patients, and duration.)

Page 82

/

(Attachment 5) f EXHIBIT IX (continued) 7.

Describe methods applicant will establish to maintain records of implantation and follow-up of patients separate from routine hospital records.

(Include procedures for assuring continuity of follow-up and determining any possible loss of follow-up with a patient.)

8.

Confirm that the applicant institution or hospital will establish appropriate control procedures to insure the physical security of the pacemakers while in the possession of the applicant. These procedures will include keeping track, by serial number, of the location of each pacemaker and requiring that they be kept under lock and key when not being used to guard against loss or theft. Confinn that all activities will be conducted in accordance with the regulations under Title 10, Code of j

Federal Regulations, Part 70.

(continued next page) 4 1

O 3

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Page 83 (Attachment 5)

EXHIBIT IX (conti nued) 9.

Describe the applicant's procedures to assure notification of appropriate individuals upcn receipt of an emergency report of inquiry concerning a pacemaker bearer.

Include written instructions to be given to telephone opera tors.

10. Confirm that the physicians responsible for and participating in the implantation program represent that they are familiar with the Coratomic C-101-P Protocol and the Coratomic C-101-P Pacer and understand that the issuance of a license is conditional upon the following of this protocol.

11. Confirm that the applicant institution agrees to continue the follow-up reporting and recovery procedures during the life of the patient and until the pacemaker is recovered and returned to Coratomic, Inc.,

P. O. Box 434, Indiana, PA 15701, even in the event the physicians named in the application are no longer associated with the applicant.

12. Confirm that packaging, labeling, and shipping instructions to be furnished by Coratomic, Inc. will be followed upon the return of the pacemaker for approved disposal.

13. The applicant nospital or medical institution herebj requests a license to receive, possess, store, and implant the Coratomic C-101-P nuclear powered pacemaker in accordance with this application.

Signed:

Applicant:

(Hospital or fledical Institution)

By:

(name and title of individual signing on behalf of the applicant)

Physicians responsible for implantation program:

l (Letter snould be signed by both an officer of the applicant and tne physicians respnnsible for the implantation program. Type or print names under signatures.)

l l

l O

Page 84 (Attachment 5)

EXHIBIT X g

INSTRUCTIONS FOR HOSPITAL OR CLINIC TELEPH0i4E OPERATORS CORATOMIC C-100 SERIES IS0 TOPIC PULSE GEf1ERATOR Nuclear Pacemaker Instructions to Operator:

1.

Accept any collect call with reference to a Nuclear Pacemaker.

2.

Any call concerning a Nuclear Pacemaker involves a patient with a nuclear pacemaker and requires im.ediate action to insure that there is no danger of radiation exposure and recovery of the nuclear pacer.

E 3.

Obtain as much information from the caller as is possible including:

Caller's Name and Where he may be Reached.

Patient's Name, Status, and Where he may be Reached.

Attending Physician (if any) and Where he may be Reached.

Infomation from Patient I. D. Card Patient's Social Security No.

Date of Implant t

Pacer Serial Number 4

Notify immediately:

Name, address, telephone number of physician responsible If he cannot be reached, notify:

Name, address, telephone number of alternative physician.

If neither can be reached, contact physician on duty for the Cardiac Care Unit; inform him that this involves a nuclear pacer; and advise him of the information you have and the argency of the matter.

I O

f

~

p, Page 85 spec

!!n?

a 1

( Attachrient 6)

QUALITY ASSURANCi: INCOMI.NG I NS P!:CT I(c' nt FITI. cap':' :S,

0.

t Capsules are loaded by a qualified labrication according tn co: : omit Specification //1141.

I.oaded capsules are delivered to Cor.iromic v rh t

a cata sheet for each capsule that includes wipe test renn: t.

i e l i n" leak test results, quantity of fuel loaded. ga mr.i i and neur n - Jow measurement, capsule material ce rt-i fi ca t i on numbers and weldio; parameters.

The following procedure will be used in the orde listed 7) l 1

Upon receipt the capsules will be lm 2ed into the i ne m ii:

.ip:

.c inspection lo" Doc.

- '115-11 and also into the I::otepit o..ct l

108 2.

Capsules will then be wipe t e u ed.

I A.

Wipe the entire exterior t r f.t ce of the fuel capsule

'eyt ci' I

the weld seans) *:ith Whituans

'1 tilter n ine r o r ec u i v. ? r 'i

+

y Uce a 1" square piece.

[' _

B.

Measure the activit'. on the wipe n.u' e :

u:. ng an

' 1 eN

' '* m meter that has been calib are-w *5a

'"'i

-i rc

.t S t a n c. a nl.

5 0 In t1J r 7,_

i l,1

,,___c_.,-__,

ninda q

1 Je a " c.li;t n p WI"'-

!i'. _.._

.in c e -

C.

Record the removable activitv in.: c r.n u i<.

in

!.c i n m itr i n -

capsule inspection !q Dc p ' : '. - 11 D.

Any capcule that sht z., no r e tun 0 0 ';

e

. curie:

f

-c

.a 3 :

s e

contamination chall be re r:o ve d

!~-

ce.

ce

'! h t

a be repaired or disposed o f :n acco-dame.ci t h the.sc ano a report nust be file-w : t !' t h e NMC w: thin fi ce d.c in tc t

'.n.

d;h the leak check condit ion of the special Nucle.r '. tre i

1.i c e n : e.

(Check 'zith Mana,,er. OA and itadiat ion a e j

Otiice: fc: decontarination and disposition.)

l 3.

Capsules will then have i neutron count performed i

ine Alpha sensing meter and the 4S8A Victoreen Geig2r ' o u:. t e :

n.

}

will be used for this.

Insure that the Alpha sensitive meter has been calibrated with the Pu-239 Alpha Standard Check the battery in the 488A Victorcen Geiger Counter.

B.

Wrap the capsule in tissue and place in the paraf fin t' r o.

C.

Place the 488A on X1 scale and fast response.

Place the external-internal switch on the Alpha sensing mete:

on t h e external position and start count D.

Record information in the i n com i ne, i nspec t i <in log thic pillS-11 Turn 438A 0FF after use w

.s.v.

' gF,

4.

Identifiying Capsules e r,. *

[

A.

The following information is scribed on each capsule r

A 3./..

eI I

w m.tx Ih c

e

- d. mA

F____,..._.---._--,.-

-n e --

- -~

T Page 86

)

Spec. /!! 102 l.

Pri c e.

( Attachment 6)

QUALITY ASSilRANCE INCOM_ING__ l._t:S PEC f 10N O F Fil_l. CA PS_lHI__S (Cont

'l' a

B.

The D is scribed firnt Set the :Je w lb. r m e s Seriber on

)

position Center capsule.ind scribe - ih) NOT SCR1HE (): UEl D

- 2v' SEAM C.

The X000 is scribed second.

Set scriber on posit:on i' 4.

Center capsule and scribe - DO NOT SCRTHE ON UF1.D 4 F A 1.

D.

Make sure information is readable on capsule.

5.

Leak checking capsules I

A.

Prei,surize capsules for Iwo h. io r..i t 100 PSI.

B.

Place in methanal and ob:.c e ve any bi.'ablem comin..

1 : or: c.au m

C.

Record information in in c om i n e, in:pection lou Do "7115-!!

u.

6.

Storing Capsules A.

All nuclear fuel capsules are stored in the safe in via:-

'k with I.D number and radioacti'.e tape around the vial j'

3.

Capsules are rel. eased from the sa fe by 0.A.

and a record kept of the disposition of each cap ule (Doc.

1115 - 1 l anti

(.

Isotopic Sources log)

SPECIAL NOTE Capsules stored in the safe far l o ne,e : t h.in ar t i'

'u-bc 9

lipe tested and in format ion recorded in Ice opic Seurces ;e:

be fore they can be released.

i' Capsules tha:. are in completed bat te rie: or pacers and kept t-Coratomic must be checked for eriissions eve:

six months b: win:

the outside of the battery or pacer or pack.io-it is con.ined a

and by checkin;; the batterv or pacer output 4

..,r,

t-01:.

+

r s

.v

.A *,'

.I Ch#

3Z3 I

h'l:#

l che cl. s ji L'at e 2/16/7FQqg..,, _ _

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