ML20246K484
| ML20246K484 | |
| Person / Time | |
|---|---|
| Site: | 07001401 |
| Issue date: | 06/01/1973 |
| From: | Mierzwiak D, Paul B VETERANS ADMIN. MEDICAL CENTER, DALLAS, TX |
| To: | Malaro J US ATOMIC ENERGY COMMISSION (AEC) |
| Shared Package | |
| ML20246K387 | List: |
| References | |
| 3637, NUDOCS 8903210594 | |
| Download: ML20246K484 (18) | |
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VETERANS ADMINISTRATION REGULATORY FILE Cy HOSPITAL 4500 S. LANCASTER ROAD DALLAS, TEXAS 75216 w
BN REPLY
-4 REFER TO:
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Atomic' Energy Commission 8
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.o, Attention:- James C.
Malaro Q,_,f 1
TMLaurens-Re:
Application for License to Implant Medtronic Alcatel Model 9000 Isotopic Pulse Generator l
Gentlemen:
The following information is submitted in application for a TM license to implant the Medtronic Laurens-Alcatel Model 9000:
1.
Applicant:
V.A. Hospital, Dallas, Texas affiliated with U T Health Science Center (formerly Univ. of Tex. Southwestern Medical School).
2.
Physician Responsible for Study:
Name:
Donald S.
Mierzwiak, M.D.
Office Address:
VA Hospital, 4500 S.
Lancaster, Dallas, Tx.
Telephone Number: *,37644$1-Ext. 473
' State Licensed to Practice In:
Missouri, Texas Medical School Affiliation:
U T Health Science Center Specialty Board Certification:
Internal Medicine Position with Applicant:
Assistant Professor of Medicine and Director, Cardiac Catheterization Lab Previous experience in the clinical use of implantable pace-makers by physician:
Played very active role in permanent pacemaker insertions over last 4 years at U T Health Science Center and Dallas VA Hospital.
Number of implants around 155 with 65 being performed at applicant's facilities.
95% of these were endocardial and 5% were epicardial.
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8903210594 890306 REG 4 LIC70 SNM-1365 PNU; yg Show veteran's full name, VA fle number, and social security number on all correspondence.
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3.
Other physicians and surgeons participating in study:
A.
'name:
William Shapiro, M.D.
Office Address:
VA Hospital, 4500 S.
Lancaster, Dallas, Tx.
Telephone Number:
376-5451 Ext. 473.
State Licensed to Practice In:
Texas Medical School Affiliation:
U T Health Science Center Specialty Board Certification:
Internal Medicine Position with Applicant:
Associate Professor of Medicine and Chief, Cardiovascular Section Previous experience in the clinical use of implantable pacemakers by physician:
A total of 150 implants, all being performed at applicant's facilities.
98% of these were endocardial and 5% epicardial.d B.
Name:
Stephen P.
- Londe, M.D.
Office Address:
VA Hospital, 4500 S.
Lancaster, Dallas, Tx.
Telephone Number:
376-5451 Ext. 553 State Licensed to Practice In:
Texas, Missouri, Minnesota Medical School Affiliation:
U T Health Science Center Specialty Board Certification:
General Surgery / Thoracic and Cardiovascular Surgery Position with Applicant:
Assistant Professor of Thoracic and Cardiovascular Surgery and VA Consultant Previous experience in the clinical use of implantable pacemakers by physician:
A total of 89 implants, 39 being performed at applicant's facilities 50 of these were performed at the Mayo Clinic and Barnes Hospita).
91% of these were endocardial and 9% were epicardial.
C.
Name:
Winfred L.
Sugg, M.D.
Office Address:
U T Health Science Center, 5323 Harry Hines Blvd., Dallas, Tx.
75235 Telephone Number:
631-3220 Ext. 512 State Licensed to Practice In:
Texas, No. Car., Missouri Medical School Affiliation:
U T Health Science Center Specialty Board Certification:
General Surgery / Thoracic and Cardiovascular Surgery Position with Applicant:
Chief, Thoracic Surgery and Associate Professor & Chairman of Thoracic & Cardiovascular Surgery Previous experience in the clinical use of implantable pacemakers by physician:
A total of 300 implants, 159 being performed at applicant's facilities 90% of these were endocardial and 10% were epicardial.
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Protocol to be followed:
MedtronicTMLaurens-Alcatel Model 9000 Isotopic Pulse Generator Protocol dated March 21, 1973.
/
Modifications to Protocol:
None 5.
Number of MedtronicTMLaurens-Alcatel Model 9000 requested to be implanted annually during study:
15_
6.
Description of physical facilities and equipment at applicant:
The Dallas VA Hospital has a less than one year old six bed coronary care unit and eight bed medical intensive care unit.
The units are equipped fully with up to date equipment including individual bed (with central station) monitoring.
They are fully staffed with specially trained nursing and paramedical personnel.
The units are under the direction of full time cardiologists and other subspecialist, along with specially designated house officers.
The operating facilities and cardiac catheterization laboratory, likewise, have been revised in the last year and fully equipped with up to date equipment.
Thus, the facilities and equipment are more than adequate to perform the study as outlined in the protocol.
7.
Description of Applicant's present pacemaker implantation and follow-up program:
The Dallas VA Hospital has been inserting permanent pace-makers since about 1968.
At present there are about five implantation per month.
At this point there have been about 300 total implantation since 1968; 95% were transvenous and 5% epicardial.
It is clear that the number of initial l
insertions are expected to stay at least the same per month, and, in addition, we will now need to start replacing the units in those patients inserted more than two years ago.
This means the number of permanents inserted per month should increase.
Since most patients prefer to return to this I
hospital for continued care, the number of dropouts and de-l-
ceased should not offset the expected increase in insertions.
I We maintain a book with names of all those patients and l
should they miss an appointment they are called by phone to l
establish proper follow-up.
The nursing personnel play a very important role in proper instruction to the patient L
concerning care and precautions with permanent pacemaker units.
1 j
The physician responsible for the study represents that he is familiar with Medtronic's Protocol and Technical Manual for the MedtronicTMLaurens-Alcatel Model 9000 and understands that the issuance of a license is conditioned upon the use of this l
1 l (.1 O
O Protocol and is conditioned on the following of the instructions in the Technical Manual regarding " Transporting, Handling and Sterilization of the Pulse Generator", and " Comments on Implantation Procedure (myocardial leads)". "
Applicant will establish appropriate control procedures to insure that the pulse generators are not lost or stolen.
These procedures will include keeping track by serial number of the location of each pulse generator and requiring that they be kept under lock when not being used.
Applicant repre-sents that it has adequate fire protection equipment in case of emergency and that all activities will be conducted in accordance with the regulations under 10 code of Federal Regu-lations, Part 70.
The Applicant agrees to continue the follow-up, reporaing and recovery procedures required under Medtronic's Protocol in the event the Physician Responsible for the Study or any other physician or surgeon participating in the study is no longer associated with Applicant.
Applicant hereby requests a license to receive, possess, store and implant the MedtronicTMLaurens-Alcatel Model 9000 Isotopic Pulse Generator in accordance with this application.
Signed:
Applicant:
'~
by Banks I.
Pual Acting Hospital Director l
l Physician Responsible for Study:
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Donald S.( Mierzwiak pM.D.
g Director, Cardiac Cath Lab and Assistant Professor of Medicine 1
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TM MEDTRONIC LAURENS-ALCATEL MODEL 9000 ISOTOPIC PULSE GENERATOR PROTOCOL DATED:
MARCH 2L 1973 I.
. INVESTIGATIONAL PROGRAM:
TM A.
Title.
MEDTRONIC Laurens-Alcatel'Model 9000 Isotopic Pulse Generator Study.
B' Purpose.
The purpose of this study is to evaluate
'the operating life of this~ pulse generator and to evaluate the system of. patient registration, follow-up, and recovery of the pulse-
. generator.as outlined in'this protocol.
C.
Description'of Unit and Related Work.
The MEDTRONIC Laurens-Alcatel Model 9000 is a demand pacemaker.
Its function is programmed from. ventricular electrical activity and is of the R-wave inhibited type.
Except for the power 1 supply and the DC to DC converter,,this pulse generator-is essentially identical to conventionally powered demand pulse generators which have been in clinical use since 1969 and have been. commercially available from Medtronic since 1969.
Implantable pacemakers in general are recognized as the treatment of choice for heart block and-several other rhythm disturbances.
They have been in widespread clinical use since 1960.
The value of this mode of treatment is documented in numerous publications in the medical literature.
The physician responsible for'the study is familiar with the first three references listed in-Exhibit I.,
Complete technical data on this pulse generator as a whole and on its isotopic power supply in particular, on radiation levels on the surface of the device and on tests to demonstrate its safety under conditions of normal use and conditions of credible accidents are on file with the U.S. Atomic Energy Commission.
1 This pulse generator has been used in patients in Europe j
since April of 1970 and in the United States since July, 1972.
The results of the first 101 implantation in Europe were reported to the European Congress of Cardiology in September 1972, by Laurens, et al (Reference 4, Exhibit I.)
D.
Plan of Investigation.
The MEDTRONIC " Laurens-Alcatel Model 9000 Isotopic Pulse Generator will be implanted us follows:
1.
Patient Selection.
The patients selected for this study will have chronic heart block or other cardiac rhythm disturbances 1
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- requiring an implantable pacemaker system.
They will be of sound mind and 18 years of age or'more.
The upper age limit will be deter-mined by a life expectancy in excess of ten years.
Patients with coexistent diseases which might limit the life expectancy to less.than ten years will not be selected for this study.
In addition, efforts will be made to select patients who are reliable subjects and who have a record of stable residence in the community such that the patient is willing to-cooperate in, and is likely to remain available for the long term follow-up required for,this study.
2 Duration of Study.
Unless results indicate otherwise, implantation under this study will continue for two (2) years.
Patient follow-up' and recovery procedures will continue -during the life of the patient and until the pulse generator is recovered.
Periodic reporting to Medtronic will continue for at least ten (10) years from the date of this first implantation.
Any unexpected adverse effects or device malfunctions thereafter will also be reported to Medtronic.
3.
Control Group.
To assure the validity of a comparison between the efficacy of this pulse generator and conventionally powered pulse generators, a series of comparable control patients with-implanted Medtronic bipolar demand pulse generators will be followed.
The control implants will be performed using the same
.procedurcs for patient selection, medical procedures, follow-up, and reporting.
4.
Medical Procedures.
A medical evaluation of the patient will_be performed and documented.
Myocardial leads (Medtronic Model 5814), will'be used with one of the several surgical approaches available to either the left or right ventricular surface of the heart.
The pulse generator will be placed into the subcutaneous tissues of the abdomen or the chest wall.
If this pulse generator is replacing another, the existing lead system may be used.
If the surgical procedures for placing myocardial leads are contraindicated for the patient because of the risks of a thoracotomy, then other surgical techniques or endocardial transvenous leads may be used.
In any event, the leads used must have a connector that is compatible with the pulse generator or compatible with a standard adaptor used with the pulse generator; splicing of leads will not be allowed.
I 5.
Medical _ Examinations.
At the time of implantation, stimulation thresholds will be measured in accordance with generally k
accepted procedures of pacemaker implantation.
At an appropriate interval following implantation, data will be secured and made part of the record indicating pacemaker function as observed before and following application of the magnet to induce asynchronous 2
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This information will be documented on the-Registration and, Implantation' Data Form for both the patient
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in the. study and thd control group (a copy of which is attached as Exhibit II).
Prior to release from the hospital, every three months -
duringLth'e first-year following implantation and every six months-the rea f ter, tlu3 patient will receive a follow-up examination which will include the securing of an electrocardiogram and-observing pacemaker function b'efore and following application of the magnet to induce asynchronous operation of the device.
Upon removal, for whatever reason, information on the reason for removal and, where applicable,. findings of autopsy will be secured.
This information will be documented on the Follow-Up Data Form for both the patients in the study and the control group (a copy of which is attached as Exhibit' III).
If any adverse effects or malfunctions related to the pace-maker system (including leads) occur, this will be documented and an opinion given as to the nature and causes of these.
An evaluation of the safety and efficacy (including period of usefulness) of the pulse generators and the procedure for its use (statement summarizing side effects, toxicity, device malfunction, degradation or failure) will be given..This information will be documented on the Follow-Up Data Form for both the patients in the study and the control group (a copy of which is attached as Exhibit III).
6.
Removal Criteria.
Determinations on the eventual removal and replacement of the pulse generator will be based on the findings of the follow-up examinations.
The pulse generator will be removed if the stimulation rate changes by more than plus or minus five beats or there is failure to capture.
The pulse generator may also be removed for other reasons in the judgement of the inves-tigating physician.
7.
Medical Records.
Medical records will be kept on each patient.
Such records will be maintained separately from routine hospital records and will include a copy of the Registration and Implantation Form and the UcIlow-Up Forma.
i II.
ADMINISTRATIVE PROCEDURES:
A.
Informed Consent by Patient.
Prior to implantation of the device, the patient will be informed as indicated in the Statement attached hereto in Exhibit IV.
This Statement will then i
be signed by the physician responsible for the study (or his designate), witnessed by another physician, and placed in the j
patient's medical records.
The informed consent of the patient will j
then be secured by use of the hospital's form for authorization of j
surgical procedures with the language in Exhibit V added.
This document will also be placed in th'e patient's medical records.
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, Identification of Patient.
Each patient.-shall carry
. 'an ' I. D.
Card ~ and ' Bracelet on his or her. person at all ' tines.
Patieit
~ may engrave information on bracelet. or piece of jewelry of his or her own: choice.
These will be furnish'ed.to the patient prior to.being discharged'. from the hospital.
1.
The.I.D. Card will be p' wallet-sized, plastic-laminated card, as follows:
(Front)
I have an implanted Medtronic'* isotopic cardiac pacemaker, Laurens-Alcatel Model 9000, it contains 2.5 curies of
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Plutonium 238.
RA IDAGT VE in case of emergency, hospitalization, or death, call collect:
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(Back)
Name Address Soc. Sec. No.
Paced Ftate Date of implant Type of Leads Pacemaker Serial Number MC 7234Dc 2.
The Bracelet (or other piece of jewelry) will be metal and engraved as follows:
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LI have;a. nuclear. pacemaker
=in' emergency,:
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hospitalization.orldcath call.' collect
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-Front (emergency gtelephone)' andLatate: " Project ~-
,F 2'38",oName of doctor,Thospital, city,. state-w.
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Back
'Medtronic Modeln9000 4'
Serial. Number-
,C.
Recovery Procedure.
The'following steps willfbe:
staken to insure recovery of-the pulse. generators:
1.
I.D.; Card and= Bracelet carry instructions for-no'tification of doctor and instituti'on in the event of emergency, hospitalization'or-death 'A.24-hour telephone contact will..be maintained at<thefnumber indicated on the 1.D. Card-and Bracelet.
M In case ~of-emergency, hospitalization or death,-~the patient or a y
ithird' party-willibe able to place a. collect call to the hospital
1
- and indicate'-that thetcall' concerns " Project 238". The' operator, upon receipt of a. call with reference to " Project 238", will have.
standing. Instructions to contact the physician responsible for.
2 the study, or his. designate. (a copy of these instructions 'is con-q.
' tainedfin Exhibit VI.
The doctor or his designate will respond-
?
and,Lif-necessary, contact-public health authorities or the licens-hing authority.
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,2.,
In addition'to the Informed Consent by Patient referredfto in-Paragraph A under Administrative Procedures granting s
permission'for' removal, the patient wil1~ grant ~ permission for re-
. moval and recovery of the isotopic pulse generator by signing a Donor-fCard~in'the form of the card in Exhibit VII,,
An executed copy of the Donor ~ Card will be retained in the patient's medical records.
The patient will be informed that the permission'may.be as broad
. as indicate,1 in lines (a) and (b) on the card or that it may be
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limited to,the pacemaker system and surrounding tissue.
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3.
The recovered pulse generators will be returned to'Medtronic for. reliability assurance analysis.
4.
The responsible physician will secure agreement by the patient to abide by the following instructions:
(a)
The patient will at all times carry the I.D. Card and Bracelet -(or other engraved-piece of jewelry).
(b)
-The patient will at all times carry on his or her person the Donor Card.
(c)
The patient will notify the hospital of any change of his address or telephone number or if there is any change in regard to his next of kin or other person to be notified in case of emergency.
(d)
The patient will notify the appropriate.
licensing authority prior.co any travel outside of the United States.
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EXHIBIT.I' Y
References 1.
Chardack, William M.:
Cardiac Pacemakers and Heart-Block.
C In Surgery of the Chest' (Chapter 38), Second. Edition, Editors John H. Gibbon, Jr., David C.
Sabiston.and Frank C.
Spencer.. Publishers -
W.B.,Saunders Co., Philadel-phia,.1969.
.2.
Chardack,-William M.:
Cardiac Pacemakers.
In Davis-Christopher's Textbook of Surgery (Chapter 53), Tenth Edition, Editor. David C.
Sabiston,'Jr. Publishers-W.B.
Saunders Co., Philadelphia, 1972.
3.
- Furman, S.
and Escher, D. J. W.:
Princi les,and Techniques-l of Cardiac Pacing.
New York, Harper and Row, 1970.
4.
- Laurens, P.,
- Piwnica, A.,
Reidemeister, C-.
and Rabago, G.:
Applications Cliniques D'un Stimulateur Cardiaque Radio-Isotopique (Abstract).
Presented at the Congress European de-Cardiologic, Madrid, Spain,-23-30 September 1972.
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EXHIBIT.II l
w REGIf"" RATION: AND IMPLANTATION DAr"'8 FORM Q,)
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'MEDTRONICTM LAURENS-ALCATEL MODEL'9000 ISOTOPIC PULSE GENERATOR A"
Please' complete.this form." Retain one copy for your records and return one copy to: _ _
Medtronic, Inc.
3055LOld Highway 8 Minneapolis,. Minnesota 55418 (please print or type) 1.
Patient Name Last First Initial Social' Security No.
Hospital Record No.
Home address City-State Zip Area Code and Telephone No.
Business address City State Zip Area Code'and Telephone No.
Name, address,.and telephone of person (s) to'be contacted if patient cannot be' located:
City State Zip Area Code and. telephone No.
Name, address, and telephone of person (s) to be contacted if patient.cannot be located:
City State Zip 1
Area Code and telephone No.:
Relationship to Patient 2.
Physician (s) and Hospital:
Name Office Address City State Zip Area Code and Telephone No.
3.
Pulse Generator:
Model No.
Serial No.
Fuel Capsule No.
Battery No.
Date of Implant Bipolar or Unipolar Placement:
subcutaneous / submuscular /intramuscular/other right/left pectoral / abdominal /other l
existing /new pocket Stimulation rate:
with Magnet without l
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Thresholdmebsdrements:
constant curre e pulse width
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other method'(describe):
4 Equipment used to take~ threshold ~
Previous implant:
Yes/No If.yes:
Manufacturer Model 0
Date of implant Why removed i'
Total number of previous implants
'4. ' Lead:
Manufacturer-
'Model No.
Serial No. (for new-leads only)
Date of implant Placement:.
Epicardial:
right/left ventricle transthoracic /transmediastinal Endocardial: vein used Previous leads (if applicable and available):
I Endocardial Number, models, and implant dates?'How many removed Epicardial Number, models, and implant dates?How many removed 5.
Clinical data:
Patient's. age Sex Race Height Weight Right handed /Left handed Etiology of arrhythmia Kind of arrhythmia
. Previous drug therapy for arrhythmia Associated diseases Temporary pacing (for initial implants only) yes/no Anesthetics used during surgery
-Antibiotics:
locally / systemically /none Cortisones or other anti-inflammatory drugs:
locally / systemically /
none Was pocket drained:
yes/no If yes, how long Did complications or adverse reaction occur in:
pacemaker / lead surgery If yes, treatment l
Comments j
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FOLLOW-UP DATA FORM' 4:
I MEDTRONIC LAURENS-ALCATEia MODEL.9000 ISOTOPIC PULSE GENERATOR
^
Please~ complete this form.
Retain one copy for your records and L
return one copy ~60:
Medtronic, Inc.
3055 Old Highway 8 Minneapolis, Minnesota.55418 (Please print or type)
]
1.
Patient Name-Last First Initial Patient' Hospital Record No.
Pulse Generator' Serial Number Date of Implantation Date 'of Follow-Up Name of Physician Name of Hospital Telephone No.
Address City State Patient'has I.D. Card:
Yes No i
Patient is wearing Bracelet or its Equivalent:
Yes No i
Contact maintained with patient:
Yes No i
2.
Pulse Generator Function:
- Satisfactory Stimulation Rate -
W M magnet Without magnet
- Unsatisfactory Comments:
3.
Summary of medical examination, including labora tory data (yearly intervals) :
4.
Removal Information:
Reason for Removal:
1
- Autopsy findings, if applicable 10 a
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EXIIIDIT IV STATEMENT
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b k-The patient has been informed that the. implantation of the' isotopic pacemaker.in. licensed only for.the purpose of clinical-investigation. Ile has been apprised of the approximate-i
. number of isotopic. pacemakers used on other patients and the result's'so far obtained with this-procedure. He has also been informed of the' availability of other forms of therapy, includ-ing the use of conventionally powered pacemakers.
The.' patient has been informed of the risks of
. radiation exposure with this pacemaker; the requirements of the Licensing. Agency for identification as having an isotopic pace-
-maker; and the patient's obligations for-tullow-up, removal'and I,
recovery of the pacemaker.
uate:
Physician Responsible for Study (or his designate) l Witness:
Date:
Another Physician 0
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3-EXIIIBIT V t
i Language to-be-Added to llospital's Form for Patient's Consent for Surgery In the event of my deat:,, I also consent to, i
authorize and request all the appropriate' medical and surgical operations and procedures in order to remove and recover the pacemaker including the removal of the-pacemaker system and surrounding tissue, if necessary, and appropriate procedures for disposal of the pacemaker by public health authorities and the licensing authority. I grant public health authorities and the
. licensing authority access to my medical records for purposes of facilitating the recovery and disposal of the. pacemaker.
I also agree to carry the proper identification as having a nuclear pacemaker,.to report to the hospital for periodic examinations as my physician has instructed and to report any change in my address or telephone number to the hospital..
i The risks and possibility of complications have been explained to me and my questions concerning this nuclear pacemaker have been answered to my satisfaction.
(to be signed by the patient and two responsible relatives of the patient) i l
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EXHIBIT VI 41 p
Proiect 238 b
Instructions to Operator:
A 1.
Accept any collect call with reference-to " Project 238';'
1 2.
Any call concerning " Project 238" involves a patient with a nuclear pacemaker and requires immediate' action to insure j
that there is no danger of radiation exposure and recovery.
of the nuclear pacemaker.
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 Patient I.D. Card)
Patient's Social Security. Number Date of Implant-1 Pacemaker Serial Number 4.
. Notify immediately:
l (Name, address, telephone number of physician responsible for-study) l If he cannot be reached, notify:
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' i.
l (alternative physician)
If neither can be reached, contact physician on duty for the Cardiac Care Unit; inform him that this involves a nuclear i
pacemaker; and advise him of the information you have and the urgency of the matter.
1 5:
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4 7~N EXIIIBIT VII'
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The DonorLCa'rd wil'1 he a wallet-sized card as follows:
.E (Front)
DONOR CARD OF Print or type name of donor, In consideration for the. implantation in me of an isotopic pace-maker, I hereby'make this irrevocable gift of-the pacemaker system l
and surrounding tissue to take effect upon my. death; ILalso'give the following other organs or parts.of my. body.to take effect upon my death:
.(a).
any needed organs or parts (b) only-the following organs or parts Specify the organ (s) or part(s)
TO Hospital (Back)
(execute two copies)
Signed by the' donor and the following two witnesses in the presence of each other:
Signature of Donor Date of Birth of Donor Date Signed City and State Donor is of sound mind and 18 years of age or more:
Witness Witness This is a - legal document under the Uniform Anatomical Gift Act, Testamentary or similar laws.
In the event of accidental death or if death if imminent, please
-call:
(Emergency Telephone Number) and Notify Operator " Project 238".
(Name of Doctor)
(llospital)
(City and State)
Y