ML20204H316
| ML20204H316 | |
| Person / Time | |
|---|---|
| Site: | 07001397 |
| Issue date: | 06/19/1973 |
| From: | Ohallaron R ST. MARYS HOSP., RICHMOND, VA |
| To: | Malaro J US ATOMIC ENERGY COMMISSION (AEC) |
| Shared Package | |
| ML20204H194 | List: |
| References | |
| NUDOCS 8810240380 | |
| Download: ML20204H316 (2) | |
Text
RGGULATORYFILE
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ST. MARY'S HOSPITAL
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June 10,1973 22g,[
Chief of Afaterials Branch Division of hiaterials Liceising 48g Atomic Energy Commission
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BOARD OF mRECrORS Washington D.C. 20515
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-4 Dishop John J. Russell Attention: Air. James C. Afalaro Chairman
Dear Afr. Afalaro:
Bishop Walter F. Sullivan vice-Chairman it is my understanding that additional clarification is needed Sister Rita Thomas relative to item #7 in our presentation dated AIny 17, 1973 in which Fre:Ident we requested an application for license to implant a Afedtronlo TA!
Mr. Joseph J. Muldowney Vic> President Prior to the release from the hospital of the unit in question, Sister Rose the hospital will, every three months during the first year following 8'l 'Y 1mplantation and cycry 6 months thereafter, see that the patient Sister Rosemarie Isertnen roccives a follow up examination which will include the securing Treasurer of an electrocardiogram and observing pacemaker functions before and following application of the magnet to induce asynchronous Mr. Mo rill M. Crowe operat' ion of the device.
Mr. Robert Grey After removal, for whatever reason, information on the Mrs. lierman cundlach reason for removal and, where applicable, findings of autopsies will be secured. This information will be documented on the f,llow Mr. Randolph W. McElroy up data form for both the patient in the study.and the control group 1.:wrence Prybil Ph.D.
(h copy of which was attuched as Exhibit 3 in our previous information).
Charles R. Riley, M.D.
If any adverso effects or malfunctions related to the pacemaker Sister niinbeth system (including leads) occur, tiils will be documented and an opinion given as to the nature and cause of these. An evaluation of the safety sister Mary Monica and efficacy (including period of usefulness) of a pulse generators and the procedure for Its use (statement summarizing sido effects, Mr. Nicholas Spinella toxixity, device malfunction, degradation or failure) will be given.
Mr. William u. Thalhimer, Jr.
This information will be documented on the Follow-Up Date Form for both the patients in the study and the control group (a copy of which is attached as Exhibit Ill).
EXECtTrlVE DIRECrOR Richard D. O'llallaron F.A.C.ll.A.
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2 It is our intention to see that the above plan is carried out by Dr. Zimberg or Dr. Pritchard, however, the hospital will maintain records according to the above stipulations and will see that such records are maintained in the event that neither Dr. Zimberg nor Pritchard are v
available for follow up.
a If there is any further information requested, please let us know, i
Sincerely, t
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L Richard D. O'llallaron, F. A. C.II. A.
Executive Director RDO'II/md c>
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