ML20133P528
| ML20133P528 | |
| Person / Time | |
|---|---|
| Site: | 07001342 |
| Issue date: | 11/20/1984 |
| From: | Klingensmith J BIOCONTROL TECHNOLOGY, INC. (FORMERLY CORATOMIC |
| To: | Glenn J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| Shared Package | |
| ML20133P439 | List: |
| References | |
| 23545, NUDOCS 8511010046 | |
| Download: ML20133P528 (1) | |
Text
O ~ O)343 C - ratomic, j
COR ATOMIC, IN C.
300 INDIAN SPRINGS ROAD P.O. BOX 434 INDIANA, PENNSYLVANIA 15701 PHONE:(412)3491811
- TELEX 86-6658 November 20, 1934 John E. Glenn, Ph.D.
United States Nuclear Regulatory Cormission Region 1 631 Park Avenue King of Prussia, Pennsylvania 19406
Dear Dr. Glenn:
We are enclosing two copies of the document " Human Implantation Protocol For The Coratomic C-101-P Radioisotope Powered Cardiac Pacer," dated March 2,1983, for your files. This protocol has been approved by the United States Nuclear Regulatory Comniission. Hospitals which apply for licenses to implant the Coratomic model C-101-P Pacer agree to follow this protocol.
Please contact us if you need additional infornation, or if you have any questions.
Sincerely,
>~hbbhejr.,m c John R. Klingensmith Patient Records Specialist enclosures (2) i g@q 5 "0mCE RECORD COPY" 8511010046 8509;.5 REC 1 LIC70 SNM-1319 PDR tgi i, b...c:A20Y l
r,ouncto ucm:ot.cov senvmc rnoic" NOV 2 61984
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l HUMAN IMPLANTATION PROTOCOL FOR I
THE COPATCMIC C-101-P l
RADI0IS0 TOPE FO'lERED CARDIAC PACER i
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March 2, 1983 i
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I 9)9 Caratomic yf
- S P. O. DOX 434. INDI AN A. PEN NSYLVANI A 15701 j
- d-PHONE (412) 3491811 TELEX 86 6658
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i CORATOMIC C-101-P RADIOISOTOPE CARDIAC PACER PROTOCOL T
l March 2, 1983 i
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1.
Description of the Pacer and Radionuclide Power Source l
i An extensive literature has arisen in connection with cardiac pacing, and selected references are listed in Exhibit 1.
The physician responsible for pacer implantation is cognizant of these and other relevant references and j
has had extensive experience in the uso af cardiac pacers.
1
}
The C-101-P pacer utilizes a programmable hybrid i
circuit, the pacing modes and operating parameters of l
which can be noninvasively changed using a coratomic hand-held programmer.
It is electronically similar to
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programmable pacers which have been in use for many years, l
l While the unit is normally used as an R-wave inhibited (VVI) pacemaker, the implanting physician may elect to use the pacer for asynchronous (VOO) pacing when appro-priate indications are present.
l 3
}
The pacing rate is programmable at 13 settings i
ranging from 38 to 120 PPM.
Pulse current can be set r
i 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 I
i normal R-wave inhibited (VVI) modo to asynchronous (VOO) i pacing by placing the sensitivity selector to its FR i
(Fixed Rate) setting.
4 The unit is hermetically scaled and shielded against lectromagnetic interference.
It has an asynchronous d magnet rate", identical to the programmed pacing rate, j
used to ascertain cardiac capture and for operational j
verification.
If high energy electromagnetic fields are l
present, the pacer will switch to a fixed rate rather l
than becoming inhibited.
t l
The fuel used for the C-101-P is plutoniu.n-238 in its oxidb form, pressed and sintered into a hard, ceramic pellet.
The isotopic battery has been so designed that excess electrical power is available at the end of a 40 year life.
The pacers have undergone extensive testing for ef ficacy, including excessive mechanical shock, impact, and vibration testing, and the nuclear fuel is contained I
in such a manner to prevent fuel release under any credibic accident, including building or auto accident, fire, fall 7
from an airplane, crushing, corrosion in sea water, or accidental cremation.
Data concerning radiation level, safety, and efficacy testing is on file with the United States Nuclear Regulatory Commission, as a Master Protocol.
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f 2.
Patient Selection Cooperative and reliable patients, who are stable, and non-mobile members of the community, will be selected I
to assure accarate long-term follow-up reporting.
I 3.
Follow-Up and Reporting i
The physician or hospital will be required to contact t
the patient at least every 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-I moved.
"In-person" follow-up visits are preferable; t
I however, telephone contacts are acceptable.
At the time i
of follow-up, patients should be reminded of the impor-l tance of carrying their I.
D, card and wearing their I. D.
1 jewelry.
Any complications or adverse reactions must be
}
reported to Coratomic by the physician or hospital.
Cor-atomic will consolidate the reporting of patients and notify the Nuclear Regulatory Commission of the results of its i
accountability program twice per year.
If the patient's j
whereabouts are unknown, Coratomic will, through its contacts i
with the hospitals and physicians, locate the patient and i
forward this information to the hospitals to provide j
complete accountability.
4.
Implantation Procedares and Leads Conventional methods of pacemaker insertion are to be j
used, ensuring as far as possible that the electrodes and leads used have an expected life comparable to the pace-
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maker and that they have appropriate pacing thresholds.
l In patients with an existing lead, the type of existing electrode must be compatible.
If not, standard adapters may be used.
Spliced leads may not be used.
- Ideally, Coratomic leads should be utilized to assure long-term I
compatibility with the pacer materials.
Myocardial or l
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endocardial leads may be used with any of the standard i
surgical approaches for lead implantation in either the
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left or the right ventricle.
The C-101-P pulse generator may be implanted in the subcutaneous tissue of the abdo-i men, chest wall, the subpectoral muscle tissue of the chest I
wall, or'any other a.ca deemed suitable by 'the responsible physician.
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5.
Stimulation Threshold Measurements The pacing threshold will be tested for all electrodes,
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j old or new, utilizing a battery-operated, calibrated
(+5% accuracy) pulse generator with an adjustable amplitude l
and of a pulse duration of
.8 to 1.2 milliseconds.
I only those electrodes may be utilized in which a threshold is demonstrated no greater than 1.5 mA if newly implanted or 4.0 mA if chronically implanted, whether i.
transvenous or epicardial, measured at a pulse width of lE
_ _ = _ - _ _
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1.0 milliseconds.
6.
Sensing Measurements If possible, the amplitude and width of the patient 's QRS wave should be measured.
Measurement should be be-tween a ground plate in the pacer subcutaneous pocket and the lead terminal distal to the heart.
7.
Registration and Implant Reports Immediately upon implantation of the C-101-P, the physician or hospital will complete a Registration and Implant Data Form, and forward it within 10 days to the Coratomic Data Center.
The form includes identification
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of the pacemaker, the patient, the physician, the hospital, j
the heart lead and adapter (if used), stimulated rate, l
and clinical data concerning the patient and his or her f
cardiac disease.
The data form is shown as Exhibit II, attached.
l 4
8.
Follow-up Data l
l The follow-up data, reported at six-month intervals, j
will be prepared by the physician or hospital and sub-mitted to the Coratonic Data Center on the Follow-up
)
Data Form (see Exhibit,III, attached).
This form summa-l rizes information on the patient and lists any complica-tions, adverse reactions or pacer malfunction.
"In-person" follow-up visits are preferable; however, telephone l
contacts are acceptable.
At the time of follow-up, patients should be reminded of the importance of carrying their I. D. card and wearing their I. D.
jewelry.
9.
Reports of Removal and Replacement l
A special form, " Pacer Failure and Removal or Patient Death," (Exhibit IV) is provided.
This form records all pertinent required data concerning the patient, physician, hospital and reasons for pacer removal and replacement, j
including whether the failure was of battery, electronic, or lead origin.
Corrective procedures and results of patient 'xaminations are also required.
e In the event of pacer removal, the pacer must be re-covered and returned to Coratomic.
The hospital and/or the physician shall notify coratomic,and the licensing agency,of the pacer removal, and Coratomic will send the proper shipping container and instructions to tre explanting institution for the pacemaker's return.
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10.
Notification of Deaths, Adverse Reactions or Malfunctions i
Notification of death is included in the form " Pacer Failure and Removal or Patient Death" (Exhibit IV).
The cause of death and autopsy findings are included. [
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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, 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 such occurrence, and Coratomic will send the proper shipping container and instructions to the explanting institution for the pacemaker's return.
Coratomic will immediately noti fy the Nuclear Regulatory Commission of the patient death.
11.
Notification of Loss of Patient Contact The hospital must notify Coratomic,and the licensing agency,within ten days of the loss of contact with a nuclear powered pacemaker patient.
This notification can be made on the Follow-up Data Form, Exhibit III, which outlines the reasons for loss of contact and steps taken to rees tablish contact.
When loss of contact is reported,
Coratomic will immediately notify the Nuclear Regulatory Commission and will pursue the patient using data from the initial implant form (Exhibit II) until a satisfactory explanation is obtained.
Coratomic will advise the hospital of their findings.
12.
Information To and Consent From the Patient a.
All patients accepting the pacemaker must agree to maintain contact with the physician or hospital as summarized above and to the removal and return to the physician (and from them to Coratomic) of the unit upon completion of its expected useful life (40 years), its failure, or upon the patient's death, whichever occurs first.
A legally binding document (Exhibit V) will be signed by the patient, a witness, the patient's spouse, and/or a relative of the patient.
b.
The patient will be required to carry an identifica-i tion card as stated in the form shown in Exhibit V.
This card is shown in Exhibit VI.
The card will identify the carrier as a radioisotope powered cardiac pacer patient, will specify the manufacturer and model number of the patient's pacemaker, specify the radionuclides contained in the pacer, and present explicit instruc-tiohs for notification of responsible parties in the event of accident or dif ficulty.
At the time of follow-i up, patients should be reminded of the importance of carrying their I.
D.
card.
The patient will also 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 agreement card shown in Exhibit VIII should be executed by the patient where possible and his or her legal guardian.
c.
The patient will also be required to carry an identi-fication bracelet or other equivalent jewelry of the medical-alert type which will carry the same patient's name and a statement to call the proper emergency
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telephone number.
At the time of follow-up, patients should be remindad of the importance o f wearing j
their I.
D.
jewelry.
This medical alert jewelry i
is mentioned in Exhibits III and IV.
I d.
The patient will maintain contact with the physician or hospi tal as discussed in 2 above, and he will be i
required to agree to do so on the informed consent form of Exhibit V.
c.
The patient will notify the hospital of any chance either in his/her address or in the names and addresses of two persons to be contacted if the patient cannot l
be located.
The patient will be required to agree to do so on the informed concent form (Exhibit V).
j f.
The patient will be required to notify the hospital of his intention to travel in foreign countries.
The hcspital vill in turn notify Caratomic, who j
vill notify the Nuclear Regulatory Commission.
The
[
patient agrees to provide this information on the i
Informed Consent Form (Exhibit V).
I 13.
Record Retention All pacer records will be maintained separately from l
the routine hospital records, either by a centralized f
authority so designated, health physics personnel, or the l
pacemaker clinic within the hospital's jurisdiction, or the physician responsible for the implantation program.
The hospital or the implanting physician will notify Coratomic of any change in the patient's address or con-dition so that Coratomic may maintain current records on the patient.
t The patient 's chart, both at the hospital and in the physician's office, must prominently indicate that the pacemaker must be retarned to Coratamic upon its removal l
from the patient for any reason.
14.
Accountability and Recoverg Under a special nuclear material license issued for implanting radioisotopic pacemakers, the patient's hospital assumes the responsibility for the control, accountability and recovery of the special nuclear i
materials (plutonium) in the pacemaker.
Conditions
(
for accountability and recovery include the follouing:
a.
The hospital shall not receive or transfer in any single transaction one gram or more of plutonium con-tained in the nuclear-powered pacemakers without noti-fying the Division of Safeguards, U. S. Nuclear Regula-tory Commission, Washington, DC 20555, and, in addition, completing and distributing Form MRC-741 as required by Section 70.54 of 10 CFR Part 70.
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b.
The hospital shall report to Coratomic, Inc. (the manufacturer of the pacemaker), and to the licensing 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 i
Commission, j
d.
The implanting hospital should normally be able to follow a patiert for life, considering that non-mobile patients are selected and that telephone contacts may i
be used for follow-up.
In unusual cases where follow-up a
difficulties are experienced, Coratomic should be con-i tacted to try to arrange transfer of responsibility to j
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 transfers responsibility in I
writing;
( 3)
The patient signs revised consent forms and receives revised I.
D.
card and I. D.
jewelry; i
(4)
The appropriate licensing agencies are notified i
of the transfer and provided copies of the documentation.
1 Following a proper transfer, the old hospital may of l
course amend or terminate its license as appropriate.
{
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,I J
I EXHIBIT I O
O REFERENCES l
- 1. Smyth, Nicholas P. D. Cardiac Pacemaking. Surgical Diseases of the Chest, Secend Edition in Press
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Editor Brian Blades.. C. V. Mosby Co., St. Louis, Mo.,1974.
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- 2. Chardack, William M. Cardiac Pacemakers and Heart Block. In Surgery of tha Chest (Cha:.t r 38).
l Second Edition Editcrs John H. Gib<an, Jr., David C. Sabiston and Frank C. Spe, ce: W. B.
l Saunders Co., Philadelphia. Pa,1000.
t
- 3. Furman, Seymour, and Eschar, Doris J. W.
Principles and Techn: ques of Card,x l'ac ng tisper and Row, New York. N.Y.,1970.
- 4. Thaten, Hilbert J.
The Artificial Carder FacemaAcr-its History, Deva.'opment and Choica!
j Application. C. C. Tnomas. Springfield.11I.,1969.
I
- 5. Hurreter, Philip; Decaprio, Vincent; and Furman, Seymour. Montefiore Hospital and Medical j
Center, New Verk, N.Y.
Endacardia! Electrog?ams and facer Se ismg; paper presented at A A*.*?
10th Annual meeting March 17-18, 1975.
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_ _ ~ _ -. _ - - - - -
ExHIBli II liiMTR U C the isotopic REG 15TRAT10N AND IflPLANTAil0N IMTA F0rdt pacemaker rnust be recovered CORATOMIC C.100 SERIES IS0TOPit PUL5E GENERATOR and returned to Coratomic l
in the event of patient Please complete this form.
CORATurilC. INC.
death or pacemaker removal.
Retain one copy for your DATA CENTER Please contact Caratomic records and return (within P. O. flox 434 for proivr shipping 10 days) one copy to:
_ cont a i ne r.
l (please print or type) 1.
Patient Name Last
~'First
~
Initial
~ ~ ~
I Social Security No.
,_ hospital Record No.
Hore Address
~A/rT7ho rie--~
Sasiness Address
~
~
~- ~ ~ -- AR T Phone fme, address, and telephone 'oUe'rDI1Ts) to be contact'ed II patient "~
cannot be located
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'LWtTonship to Fatient
~ ~ ~
~~
" ' ~
hame, address, and telepfion~eTalter nite person (~5T to 1>e contacted it -
=
patient.cannot be located A/C & rho'e ReTatTonship to Fatient
~~~
2.
Physician (s) and HospitalT~~~~ ~~~~"
"~
~
Name
~ ~ ~ ~ ~
'T/C & Phone
~ ~ - ~
~
3.
FiFoIsotope Powered Pacer Tniomatton:
~~"
Serial No.
Date of implant Macerent: s ubc u t a n eous /s uT&s c u l a r/ i n t r ams c 'Ta r/o tTir
~ ~ - ~ ~ ~ ~
u ri gh t/ l e f t pec to ra l / abdomi nal /o the r existing /new pocket 5tirolation rate: with Magnet witaout Threshold wasurements: voltage currenf~~~~
pulse width _
other method (describe):
i
[quipment used to masure threshold _ _
~~~_~~~~~[____
j 4
Frevicas Implant Information:
ves 'th Tf yes:
(
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llanufacturer
,_ tlodel
___ Date of implant Wny removed Total number or previous impfants
" ~ ' ~ ~
5.
Lead; fianufacturer
~ KJeT10.
i 5crial No. (for new Teads o'n'ly) ift ieEt'rTcTe~~~
Placement: Myocardial: right/l ~
Ta't'c3 f implan t
- ~ ~
transthoracic /transwdiastinal Endscardial: vein used Previous leads (if appitcable and avalTalle):
Myocardial: hJnber, models, and i@lant dates; how many removed?
Endocardial: Number, models, and implant dat35 ; how many removed?
6.
Clinical data:
Patient's age Sex Pace height Right Tianded/tef t hand'id Weight
~
~
Etiology of arrhythmia Kind of arrhythmia
~ ~ ~ ~
r
~ ~ ~ ~ ~
Previous drug therapy for arifiyIhirIT
, " * * ~
~
Associated diseases i
Temporary pacing (for initial impTants only)
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~~
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Anesthetics used daring surgery Antibiotics: locally / systemically /none Cortisones or other anti.inflamatory drugs: localJy/ systemically /none Was pocket drained:
Yes No if yes, how long?
Did complications or adverse reactions occur in pachaker/WOIsurgeryTZ i
If yes, treatment j
Coments
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LXHIBif !!!
j 'lHPDRTAMie IsotopTc-FOLL0w UP DATA FORM I paceruker must be recovered CORATOMIC C.100 SERIES ISOTOPIC PUL5E GENERATOR and returned to Coratomic l death or pacemaker renoval.
in the event of patient Please complete this fom.
CORAT0f t10. INC.
Retain one copy for your DATA (ENTER Please contact Coratomic records and return (within P. O. Don 434 for proper shipping 10 days) one copy to:
1.
Patient Name
~'~
Last First Ini t tW~
Social Security No.
_ Hospital Record No.
i Hone Address l
A/C Dhone Business Address T/CY Phone Nihe, address, and telephore of penon(s) to be cnnt'a'ct'ed if patient
~
cannot be located
_ =..
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Felationship to Patient
~
Name, address, and telepEo'ne of alternate person (s) to W rontacted if patient cannot be located A/C 1 Phon ['
Relationship to Patient I
2.
Physician (s) and Hospital:
" " ~ ~
Name Office Address i
~ fiC T lhone 3.
Radioisotope Fowered Pacer Infor1 nation:
Serial No.
Date of inplant Date of follow up l
Was follow up an Triperson" visit or telephone contact?
Was patient reminded of the importance of carrying 1. D. card and wearing i
- 1. D. jewelry?
Yes No Patient has I. D. card Yes
' No Patient is wearing Bracelet o'r'its EquGilent:
Yes No C-100 Series Pacer Information: Satisf actory - UnTittsfactory ~
Stimulation Rate:
with Hamet without flagnet __ _ T List any complications, adverse reactions, or pacer rialfunction:
=...
.=
=
Has any repair, relocation or replacerent71MIbeen necessary? yes/no ~
t 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-estallTs'h contactTZ-i I
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EXHIBIT IV IMPORTANT: The isotopic PACER FAILURE AND REMOVAL pacenukei nust be recovered OR PATIENT DEATH FORM and returned to Coratomic CORA10MIC C.IW) SERIES 150TOPlc PUL5E CENERATOR in the event of patient deJth or pacemaker renoval.
Please complete this form.
CORATOMIC. INC.
Please contact Coratonic Retain one copy for your DATA CENTER for proper shipping records and return one P. O. Box 434 j~ container, copy to:
Patient Name Last First inTtial Social Security No.
Patient Hospital Record No.
Pulse Generator Serial No.
Date of Follow-up
~.Date of Implantation l
Name of Physician
~
Name of Hospital
, Telephone No. _
Address I
City 7 tate lip
~ ~ ~ ~
~
~ ' ~ "
Patient has 1. D. card:
Yes No P3tient is wearing Bracelet or'Tt's Equi 7aTent:
Ves
'.o i
How was pacemaker disposed of?
I 2.
Pacer Failure i
Battery failure Lead Failure
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Oescription of FaTure
~
llectronics Failure ~
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Grrective Procedure Due toTaBure
~~~
l Replaced Pacer 4
Model and Serial'Yunber of Replacenent
' ~ ~ " ~
Replaced Lead Model and SeriiTNumber of Replacement Lead 3.
Pattent Death
~ ~ ~ ~ ~
Cluses of Death Autopsy Findings t
~
l' Was facer functioning at time of death? les lo Was Lead functioning at tire of death? Yes No 4.
Sumary of Medical Examinations (if other tfiin' dNtU eme-* --
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ruffiT V INFORMED CONSENT FOR SURGICAL IMPLAn1M10N OF RADIO!50 TOPE POWERED CARDI AC PACER CORATOMIC C-100 SERIES 15010PIC PUI.5E GENERATOR 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 understand that the surgical procedurv may/will 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 pacer to be used for the implantation is a radio-isotope powered cardiac pacer nanufactured by Ceratomic. Although the pacer has been extensively tested, there is no 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 life expectancy in excess of 40 years. I l
understand that the cardiac pacer does produce radiation, but that this radia-
"l tion is negligible.
fince the device cnntains radinisotopa ruterial (Plutonie239), ultimately, af ter my death or earlier, if the useful life nf the pJcer is eAceeded, if it ceases to function effectively for my medical needs, or if I request to have it removed, the pacer must be returned to Coratomic via (licensed institution). Accordingly, I agree to contict (institution) at least every six months, and whenever I change my residence.
I will always carry the appropriate identification card on my person, and will at all times carry the Uniform Anatomical Gif t Act donor card and wear eith r a medical alert bracelet or its equivalent.
Notwithstanding my contacting the implanting institution following the insertion of a cardiac pacer of any sort, I am advised to remain in contact
)
with my personal physician.
I agree to notify the hospital, who will, in turn, notify Coratomic of my l
intention to travel in foreign countries. Coratonic will, in turn, notify the Uclear Regulatory Comnission.
I agrte to provide the hospital with the navs addresses, and telephone numbers of two persons to be contacted if I carnot be located. ! also agree to notify the hospital of any changes in tho nyes, addresses, or telephe e nucters of the two persons to be contacted.
I agree to maintain contact with my physician at least every six months following the insertion of the pacer. Fu'thernore, I consent to disclosure by the (linic or Coratomic of any inforriation acquirrd D/ the clinic in regard to the implantation of the radioisotope powered cardiac pacer, prcvided, however, in no event shall disclosure other than to Caratomic include my identification without my specific written approval.
a I have had the opportunity to ask questions pertaininq to the surgical procedure, the radioisotope powered cardiac pacer. and the follow-up procedure.
1 The possible alternate methods of treatnent, including the use of convention 51 chemical battery pan,ered pacers have been called to my attention.
With these facts in mind and intending to be legally bound, I hereby I
authorize the surgical procedure whereby the Coratomic 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 ultimate return of the unit as detailed above.
Witness (Date) pitEnPUEniture or persnn (dye 7 authorlied to consent for the patient DT tiorIsinp to the patient sigidng if i
Please sign 3 copies:
other than the patient i
1 copy to patient I certify that I have esplained the I cnpy to hospital above prncedate i
I copy to Coratomic D~r'.~~~~~' ~ ~ ~ ~~~
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1 EXHIBIT VI PATIENT IDENTIFICATION CARDS CORATOMIC C.100 SERIES ISOTOPIC PULSE GENERATORS (Front)
Caratomic.
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EXHIBIT Vl!
a DONOR CARDS FOR ADULTS CORATOMIC C-100 SERIES PULSE GENERATOR (Front)
Coratomic
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EXHIBli VI!!
DONOR CARD FOR ftINOR$
CORATOMIC C-100 SER!ES ISOTOPlc PULSE GENERATOR (Front) k Caratamic, W ::.:: n -- ::::..
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EXHIBIT IX SUGGESTED APPLICATION FORMAT FOR NUCLEAR POWERED PACEttAKERS l
CORAT0t11C C-101-P ISOT0plC PULSE GENERATOR i
Send to:
1 Material Licensing Branch Or - Agreement State Licensing Agency U. 5. Nuclear Regulatory Comission (if appropriate)
Washington, DC 20555 4
Re: Application for license to participate in the implantation of Coratomic t
C-101-P nuclear powered pacemakers, each containinD 250 milligrams of Pu-238(<4.3 curies).
Gentlemen:
i The following information is submitted in application for a license to i
participate in the implantation of Coratomic C-101-P nuclear powered pacers.
1.
Applicant:
(Hospital or fledical Institution) a a
1 (Address) l (State and Zip Code) 2.
Physicians responsible for implantation program: (Provide this infcrmation r
for EACH physician involved)
Name:
Office Address:
Telephone Number:
State Licensed in Which to Practice:
=
Specialty Board Certification:
Position with the Applicant:
i Previous experience in the implantation and follow-up of pacemakers by physician:
(include duration of pacemaker experience, total number of 4
implants physician has done, and the total number he has done at the applicant's facilities.)
\\
- 3.. Protocol to be followed:
HUMAN IMPLANTATION PROTOCOL FOR THE CORAT0f1IC C-101-P RADI0 ISOTOPE.
j POWERED CARDIAC PACER, DATED MARCH 2,1983.
1 4 A maximum of ~
i annually.
- Coratomic C-101-P pacemakers is requested to be implanted 4
5.
Description of physical facilities and equipment at the applicant institution or hospital:
4 (Include description of cardiac care unit and operating facilities and i
list specific equipment needed and available for the implantation i
program; include equipment for measuring stimulation thresholds,
}
threshold parameters, and overall pacemaker function.)
Description of applicant's present pacemaker implantation and follow-up 6.
program: (Include size,1. e., number of patients, and duration.)
l 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 wit,h 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 i
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. Confirm that all activities will be conducted in accordance with the regulations under Title 10. Code of Federal Regulations, Part 70.
(continued next page)
~
EXHIBIT IX (continued) 9.
Describe the applicant's procedures to assure notification of appropriate individuals upon receipt of an energency report of inquiry concerning a pacemaker bearer. Include written instructions to be given to telephone operator:.
- 10. Confinm 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. fonfirm that packaging, labeling, and shipping instructions to be furnished by Coratomic, Inc. will be followed upon the return of the pacereker for approved disposal.
- 13. The applicant hospital or medical institution hereby requests a license to receive, possess, store, and implant the Caratomic C-101-P nuclear powered pacenuker in accordance with this application.
Signed: Applicant:
~
(Hospital or I1edical Institution)
By:
(name and title of individual signing on behalf of the ppplicant)
Physicians responsible for implantation program:
(Letter should be signed by both an of ficer of the applicant and the physicians respnnsible for the irplantation program. Type or print names under signatures.)
e
EXHIBIT X INSTRUCTIONS FOR HOSPITAL OR CLINIC TELEPHONE OPERATORS CORAT0tilC C-100 SERIES IS0 TOPIC PULSE GENERATOR 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 innediate 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.
Attending Physician (if any) and Where he may be Reached.
Information from Fatient I. D. Card Patient's Social Security No.
Date of Implant 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 urgency of the matter.
9
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