ML20211K446
| ML20211K446 | |
| Person / Time | |
|---|---|
| Site: | 07001402 |
| Issue date: | 02/21/1974 |
| From: | Buchanan C US ATOMIC ENERGY COMMISSION (AEC) |
| To: | George M ABINGTON MEMORIAL HOSP., ABINGTON, PA |
| Shared Package | |
| ML20211K358 | List: |
| References | |
| NUDOCS 8606270401 | |
| Download: ML20211K446 (2) | |
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UNITED STATES f[ Dh l
ATOMIC ENERGY COMMISSION b
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WASHINGTON D.C. 20545
%,4],f L:MB:JMB FEB E 1 1974 (SNM-1412)
Abington Memorial llospital ATTN:
Mr. Morris F. George President 1200 York Road Abington, Pennsylvania 19001 Gentlemen:
To effect the control radioisotopic powered pacemakers implanted during
- he investigational program and to provide for consolidation of data, we propose to amend your present License No. SNM-1412 by including the i
l following conditions:
The license shall report to the Materials Branch, Directorate of Licensing, USAEC, Washington, D.C.
20545, 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 pacemaker bearer, and any adverse reaction and/or malfunction involving a pacemaker system, including the leads. A written report giving the details of the adverse reaction and/or malfunction shall be submitted within 30 days.
The licensee shall report to the Materials Branch, Directorate of Licensing, USAEC, Washington, D.C.
20545, within 10 days, loss of contact with a nuclear pacemaker bearer.
The licensee shall continue patient follow-up and replacement procedures for the nuclear pacemaker during the life of the patient; and procedures for recovery and authorized disposal of the nuclear pacemaker by return to Medtronic, Inc., shall be followed upon the death of the patient.
This notice is sent to you so that prior to institution of formal proceedings for modifications of your license, you may have an opportunity to consent to these changes.
If you are willing to 8606270401 860008 REG 1 LIC70 SNM-1412 PDR
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Abington Memorial Hospital.
have these conditions added to your license without the issuance of a formal order, please notify us within 20 days of this notice.
If we do not receive your consent, formal action will be. instituted to modify your license.
Sincerely, sj' l
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Cecil R. Buchanan, Asst. Chief
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Materials Branch Directorate of Licensing I
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