ML20204H327
| ML20204H327 | |
| Person / Time | |
|---|---|
| Site: | 07001397 |
| Issue date: | 05/17/1973 |
| From: | Ohallaron R, Zimberg Y ST. MARYS HOSP., RICHMOND, VA |
| To: | Malaro J US ATOMIC ENERGY COMMISSION (AEC) |
| Shared Package | |
| ML20204H194 | List: |
| References | |
| 3453, NUDOCS 8810240384 | |
| Download: ML20204H327 (7) | |
Text
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May 17, 1973 co BOARD OF DIRECTORS 8
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Lishop John J. Ru6 sell Chief'of Materials Branch bW29f
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Division of Materials Licbnsing Ram Chaftman
,$,,(,7 tishop Walter F. Sullivan Atomic Energy Commission Y
9 vice-chsfrmon Washington, D. C.
20545 Attention:
Mr. James C. Malaro
-Ms' s stor ta noin6s p,.,
TM Mr. Joseph J. M ddowney RE:
Application for License to Implant Medtronic vice-Presiden Laurens-Alcatel Model 9000 Isotopic Pulse nerator Stater Rose Secretary Gentlemen Sister Rosemariv Iserman The following information is submitted in application TM Mr. Morrill M. crowe for a license to implant the Medtronic Laurens-Mr. Robert Grey Mrs. Ilerman cundlach 1.
Applicant ST. M7RY'S HOSPITAL Mr. Randolph W. McElroY St. Mary's Hospital is a 350-bed, private, n n-profit hoopital, accredited by the Joint t.awrence Prybil, Ph.D.
Commission on Accreditation, serving the chules R. Riley, M.D.
west end of Richmond and surrounding areas -
a general hospital with all medical and surgical Sister Elizabeth specialities represented.
The hospital is affiliated with the Medical College of Virginia sister Mary Monica in a pediatric rosidency and has other teaching Mr. Nicholas Spinella affiliations for OXterns.
Mr. William B. %elhimer, Jr.
EXECimVE DIRECTOR YALE H. ZIMBERG, M.
D.,
Thoracic Surgeon Ricbrd D. O'llallaron F.A.C.ll.A.
8810240384 C30603 REG 2 LIC70 SNM~1375 PNU f 4s Ei
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}.lo Id en 4 U S* ' I m/n yp (703) 285 2011 RICliMOND, VIRGINI A 23220 5801 DREMO ROAD
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s 2c33 Mr. Jascas C. Malaro Page No. 2 May.17, 1973 3
Other. physician participating in study:
GEORGE E. PRITCHARD, M.
D.,
Cardiologist (Descriptive background.of the participating thoracic surgeon and cardiologist are enclosed on separate sheets.)
9 T
Medtronic ELaurens-Alcatel Model 9000 4.
Protocol to be followed:
Isotopic. Pulse Generator Protocol dated March 21, 1973.
15.
' Number of Medtronic Laurens-Alcatel Model 9000 requested to be implanted annually during study:
Initially requesting five (5).
6.
Physical facilities' and equipment at St. Mary's Hospital:
Modern operating rooms with -personnel fully familiar with myocardial and endocardial pacemaker implantation.
X-ray facilities with TV viewing are available for insertion of endocardial catheters and implanting pacemakers.
This area-in the X-ray Department is under the combined surveillance of the Operating Room and the X-ray Department.
A 5-bed Cardiac Caro Unit and a 5-bed Intansive Care Unit are available.
The Cardiac Care Unit has monitoring devices for each bed and resuscitation equipment is maintained in the unit.
2 Nursing personnel are thoroughly familiar with pacemaker units and their operation.
External pacemakers are avellable to check milliampero and a l
volt-ohmeter is available for checking pacemakers.
Ethylene oxide sterilization is available and used for pacemaker equipment.
4 Repair kits for pacemakors are available.
'7 Follow-up Program:
I Q) The hospital proper does not have an cngoing program for oacemaker c
follow-up.
This is carried out in the individual thoracic surgeon's
[ ' Nand cardiologist's offices.
A program of battery replacement for e V J'
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~ Mr. James C. Malaro
~Page No. 3 May 17, 1973-7.
Follow-up Program (continued) the conventional units has been set up similar to the guides advocated by the Medtronics Company.
All of the pacemakers implanced by the participating surgeon have been Medtronic endocardial demand typo units with three exceptions.
One patient has had a unipolar pacer inserted becense of malfunction of one wira and two patients have had myocardial electrode implantations because of failure to achieve satisfactory pacing with che endocardial catheters.
Dr. Zimberg and Dr. Pritchard, the physicians resIonsible for the ntudy, are familiar with the Medtronic's Protocol and Technical Manual for the MedtronicTMLaurens-Alcatel Model 9000, r: is understood that the issuance of a license is conditioned upon the use of this Protocol and is conditioned on the following of the instrtctions in the Technical Manual regarding "Transporting, Handling and S'cerilization of the Pulse Generator", and "Comments on Implantation Procedure (myocardial leads) ".
Applicant will establish appropriato 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 represents that it has adequate fire protection equip-ment in case of emergency and that all activities will be conducted in accordance with the regulatio"s under 10 Code of Federal Regulations, Part 70.
The Applicant agrees to continue the follow-up, reporting 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.
TM l
The first recipient of a Medtronic Laurens-Alcatel Model 9000 Isotopic Pulse Generator will be a 25-year old woman, married, mother, housewife 4
and part-time student.
Copy of an individual release signed by this patient is enclosed.
The patient is due for a battery change within the r
I very near future and expeditious handling of this request would bo in the best interest of this patient.
l M53 l
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O Mr. James C. Malaro Page No, 4 May 17, 1973 Applicant hereby requ ts a license to receive, pcasess, store and implant the Medtronic urens-Alcatel Model 9000 Isotopic Pulse Generator in accordance with t.his application.
ST. MARY'S HOSPITAL
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R'ichard D. O'Hallaron, F.A.C.H.A.
Executive Director Physician Responsible for Study f
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RDO'H/py Enclosures (3) cc:
Medtronic, Inc.
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' PHhSICIAM'RESPONSIB FOR STUDY:
Names YALE H. ZIMBERG, M. D.
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r Address: (office) 5700 Old Richmond Avenue; Richmond, Virginia 23226 t
Telephone (bffice): 285-3225 or 285-1847 State Licensed to Practice In:
. Virginia-t i
Medical School Affiliation:
Medical College of Virginia (Class of 1951)'
Clinical Professor of Surgery-Consultant to V. A. Hospital (Richmond)
Specialty Board certification:
General Surgery
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Thoracic Surgery Position with Applicant:
Attending Physician in Thoracic Surgery Previous experiences Began using pacemakers in 1960.
Did animal work on pacing and infarct patterns in dogs at the V. A. Hospital, Richmond.
Heartblock was pro-duced experimentally in dogs by tying the A-V nodes _on extra-corporeal by-pass.
Did one of the first, if not the first, myocardial pacemaker in Virginia at V. A. Hospital in 1960 or 1961.
collaborated verbally with Dr. Chardack on early pacemakers.
Spent time at the Buffalo V. A. Ilospital observing techniques of Drs.
Chardack and Gago.
Attended the course on pacemakers at the Buffalo
!!ospital in the early.1960's.
Implanted over fifteen myocardial electrodes (exact number unavailable at this time, since work was done t
at V. A. I!ospital when I was Chief of Thoracic Surgery).
In the past f
six years, I have only dono four myocardial implantations for patients j
who were not candidates for endocardial leads or for patients where endocardial cathotors could not be placed satisfactorily.
I Itavo implanted at least sixty pacemakers since 1968 while being in I
privato practice.
!! ave had additional exposure in cardiac catheriza-f 1
j tion at the V.A. Hospital collaborating with Dr. Eric Kemp and Dr.
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My experience to date includes a large number of myocardial and l
endocardial implants and a considerable exposure to experimental heart-block and pacing in the dog.
All the pacomakers implanted have been Metronic units and exact numbers can be obtained from the filos of Motranic, Inc.
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aan C A R DI O LO'G Y CLINIC, INC.-
. G:orge E. Pritchard. M. D.
50o1 GROVE AVENUE Telephone 288-8257 R:CilMOND, VIRGINIA 23226 May 16,1973 In re:
Mrs. Isabella Grantham r 1.
Applicant:
St. Mary's Hospital, Bremo Road Richmond, Va.
2..
Physician Responsible for study:
Dr. Yale Zimberg, Thoracic Vascular Surgery Libbie and
- .d Richmond Avenue, Richmond, Vc.
285-3225
'3.
Other physicians and surgeons participating in study:
George E. Pritchard,M.D.
Office address:
5001 Grove Avenue Richmond,Va. 23226 Telephone Numbec; 288-8257 State Licensed to practico in:
Virginia Medical School t
affiliation:
. Medical College of Virginia-Clinical instructor Specialty Board Certification:
Board eligible American Board of Internal Medicine, Board eligible American Board of Cardiology Training completed Internal Medicine two years at the Cleveland Clinic in
-Cleveland, Ohio Cardiology, two years at the Cleveland Clinic, Cleveland, Ohio Position with applicant:
Cardiologist Previous experience in the clinical use of implantable Approximately 25 patients from my private pacemakers by physician:
practice of Cardiology have been sub-mitted for implantable demand cardiac pacemakers and are currently being followed by me.
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urnicu v i,we r erstru 8 700 OI f t IflClf tf tlNll AVINtE UTClf 4f 0 'iD.
Vlif fetNI A 23206 f:ay 14, 1973 rniin A re A si nicos,inc mr r,,,,.,u,. -m.2 m I Altl.itlV 4 4# 1 f. A lf N f ' lli, F l. Y TO WHOM IT MAY ('ONCEIW:
Thin in to ntate that I have been informed that the implantation of the isotopic pacemaker.tn licenced only for the purpone of clinical inventigation.
I have been apprined of the appros:imate number o f inot.opic pacemakero une 1 on other patients and the l
rest.i ts no far obt.ained with thin proced :ro.
I have alno been informed of the avai. lability of other forno of therapy, including the une of conventionally powered pacemakern.
I have been informed of ne rinka of radiat:f on exponure with this pacemaker; the requ retrents of the Licensing Agency for identi fication an having an inotopic pacemahor; and the l
obligations for fo l l ow-u p, removal and recovery of the pacemaker.
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I hereby certify that I have been advined of the foregoing and fully underntand narre and concent to name, and including, but 5
not 1imited to, the fact that I recognine that I am ntill tf chil d bea rinct ago.
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