ML20128E174
| ML20128E174 | |
| Person / Time | |
|---|---|
| Site: | 07001336 |
| Issue date: | 05/29/1973 |
| From: | Rodriguez H PONCE DISTRICT HOSP., PONCE, PR |
| To: | Mason J US ATOMIC ENERGY COMMISSION (AEC) |
| Shared Package | |
| ML20128E094 | List: |
| References | |
| 3615, NUDOCS 8507050272 | |
| Download: ML20128E174 (2) | |
Text
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ESTADO LIDRE ASOCIADO DE PUERTO RICO
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DEPARTAMENTO DE SALUD
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DOCKET N -
y F3 Mr. James R'. Mason Materials Branch Directorate of Licensing United States Atomic Energy Commission Washington, D.C.
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Docket No. 70-1336 9/M i343
Dear Mr. Mason:
Thank you for your communication of May 23, 1973 regard-ing our application for a special nuclear material license to implant Medtronic Model 9000 nuclear powered cardiac pacemaker.
TM I have carefully reviewed the Medtronic Laurens-Alcatel Model 9000 Isotopic Pulse Generator Protocol dated March 21, 1973 and wish to amend our application to include this protocol instead of the one previously submitted by me in
.our application.
The requirement of studying and report-ing a comparable group of control patients with conven-tional battery powered pacemakers to Medtronic, Inc. will be closely fulfilled as well as the rest of the protocol requirements.
I have filled part 4 of Exhibit VI and have enclosed it with this letter.
No modifications will be made in the standard protocol.
I am also sending you the committment letter from our insti-tution to continue the study in the event the undersigned as Project Director and the other investigators in our group are no longer associated with the institution.
Sincerely yours, Md Hector F. Rodriguez, M.D. FACP, FACC.
Director Cardiorenal Division go y
850530 Ponce District Hospital Box 1306 SNM-1951 ppg Ponce, Puerto Rico 00731 3615 HFR:ges'
APPLICATION R LICENSE TO POSSESS AND LANT NUCLEAR POWERED CARDIAC PACEMAKERS IN HUMANS CARDIORENAL DIVISION PONCE DISTRICT HOSPITAL PONCE, P. R.
00731 EXHIBIT VI Proiect 238 Instructions to Operator:
1.
Accept any collect call with reference to Project 238.
2 Any call concerning " Project 238" involves a patient with a nuclear pacemaker and requires immediate action to insure that there is no danger of radiation exposure and recovery of the nuclear pacemaker.
3 Obtain as much information from the caller as is pos-sible 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 Pacemaker Serial Number 4.
Notify immediately:
H6ctor F. Rodriguez, M.D.
4 Obispado Street Tel. No. 842-2080 Ext. 310 and 236 Ponce, Puerto Rico Cardiorenal Division 842-6064 Home Phone If he can not be reached, notify:
Victor Carlo, M.D.
C-56 Urb. El Monte Ponce, Puerto Rico Tel. No. 842-2080 Ext. 310 and 244 Cardiorenal Division 843-2512 Home Phone If neither can be reached, contact physician on duty for the Cardiac Care Unit; inform him that this involves a nuclear pacemaker; and advise him of the information you have and the urgency of the matter.
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