ML20212D763

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License SNM-1969 for Veterans Admin Medical Ctr,Authorizing Use of 210 Mg Pu-238 Sealed Source in Nuclear Powered Cardiac Pacemaker for Clinical Evaluation Purposes
ML20212D763
Person / Time
Site: 07003042
Issue date: 07/28/1986
From: Kinneman J
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
To:
Shared Package
ML20212D767 List:
References
NUDOCS 8608120566
Download: ML20212D763 (4)
v • d • e


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p PAGE OF PAGES 4 84 U.S. NUCLEAR REGULATORY COMMISSION MATERIALS LICENSE i

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Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93 -438), and Title 10, I Code of Federal Regalations, Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations.

i heretofore made by the licensee. a license is hereby issued authorizing the licensee to receive, acquire, possess, and transfer byproduct, source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below;to l deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This j l license shall be deemed to contain the conditions specified m Section 183 of the Atomic Energy Act of 1954, as amended, and is i subject to all appheable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any ;

conditions specified below.

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Licensee l

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1. Veterans Administration Medical Center
3. License number ShM-1969
2. 800 Poly Place j

Brooklyn, New York 11209

4. Expiration date July 31, 19SO j

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5. Docket or llA. Plutonium (Principal Reference No.

SNM-1828 070-02876 y

6. Byproduct, source, and/or
7. Chemical and/or physical S. Maximum amount that licensee special nuclear material form may possess at any one time under this license i,

A.Sealedsource(s)

A. 210 milligrams radionuclice Fu-238) 9.

Authorized use

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Implantation in humans as a component of a Laurens-Alcatel Model 9000 nuclear powered cardiac pacemaker for clinical evaluation purposes.

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CONDITIONS M

10. Licensed material shall be used only at 800 Poly Place, Brooklyn, New York.

I 11. The specified possessier: limit includes all licensed material possessed by the

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licensee under this license whether in storage, implanted in patients, or j

g; otherwise in use.

g4 12. The licensee shcl1 report to the U.S. Nuclear Regulatory Commission, Region I,

't ATTN: Chief, Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, t

i King of Prussia, Pennsylvania 19406, 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

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of any nuclear pacemaker patient, and any adverse reaction and/or malfunction involving a pacemaker system, including the leads. A written report giving g

details of the adverse reaction and/or malfunction shall be submitted within g

i 30 days.

4, 4 13. The liter.see shall report to the l'.S. Nuclear Regulatory Commissicn, Region I, 3

ATTN: Chief, Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, l

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King of Prussia, Pennsylvania 19406, within 10 days of loss of contact with a j-

'g nuclear pacemaker patient.

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g 4; 14. The licensee shall continue patient follow-up and replacement procedures for l

8, the nuclear pacemaker during the life of the patient.

Procedures for recovery j

and authorized disposal of the nuclear pacemaker by return to the manufacturer shall be followed upon the death of the patient, go M

8608120566 860728 i

REG 1 LIC70 wwwmaraerMTEJFMECTdMhT&TX.72EEC

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li NRC Form 374A U.S. NUCLEAR REGULATORY COMMISSION 2

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SNM-1969 MATERIALS LICENSE k

SUPPLEMENT ARY SHEET 070-03042 I

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SNM-1828 070-02876 k

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CONDITI0h5

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15. Except as specifically provided otherwise in this license, the licensee shall g

I conduct its program in accordance with the statements, representations, and i

I procedures contained in the documents including any enclosures, listed below.

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The Nuclear Regulatory Commission's regulations shall govern unless the state-1

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l ments, representations and procedures in the licensee's application and corre-spondence are more restrictive than the regulations, y

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Application dated May 20, 1986 I

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PAGE OF A E 4 W84 U.S. NUCLEAR REGULATORY COMMISSION I

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MATERIALS LICENSE j

4 Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93 -438), and Title 10, y Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations y

$ heretofore made by the beensee, a license is hereby issued authorizing the licensee to receive, acquire, posse 4 source aad special nuclear muerial designated below; to use such material for the purpose (s) and at the placc(s) designated below; to 4' deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This l' k license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amended, and is subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any 4 conditions specified below.

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k Licensee f[

i 1-Veterans Administration Medical Center

3. Ueense number ShM-1969

$lE 2 800 Poly Place L;

Brooklyn, hew York 11209

4. Expiration date July 31, 1990 4'

070;03042 f

5' Docket or Reference Ne.

SNM-1828 070-02876

6. Byproduct, source, and/or
7. Chemical and/or physical
8. Maximum amount that licensee Ej special nuelear material form may possess at any one time j

f under this license i'

fA. Plutonium (Principal A.Sealedsource(s)

A. 210 milligrams radionuclioeFu-238) g lp'i 4

P s 9.

Authorized use d.

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Implantation in humans as a component of a Laurens-Alcatel Model 9000 kj

'd nuclear powereo cardiac pacemaker for clinical evaluation purposes.

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CONDITIONS g

i 10.

Licensed material shall be used cnly at 800 Poly Place, Brooklyn, New York.

k 11. The specified possessier limit inclucEs all licensed material possessed by the licensee under this license whether in storage, implanted in patients, or g

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otherwise in use.

4 (t4 12.

The licensee shcIl report to the U.S. Nuclear Regulatory Commission, Region 1, i,

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Chief, Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue, i

4 King of Prussia, Pennsylvania 194CC, within 24 heurs of occurrence, the death f

of any nuclear pacemaker patient, and any adverse reaction and/or malfunction j

involving a pacemaker system, including the leads. A written report giving q

p details of the adverse reaction and/or malfunction shall be submitted within 4

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30 days.

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hj The liter.see shall report to the U.S. Nuclear Regulatory Commissicn, Region I, b

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Chief, Nuclear Materials Safety and Safeguards Branch, 631 Park Avenue,

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King of Prussia, Pennsylvania 19406, within 10 days of loss of contact with a g

q, nuclear pacemaker patient, j*

4:'4! 14. The licensee shall continue patient follow-up and replacement procedures for l

4 the nuclear pacemaker during the life of the patient. Procedures for recovery 4

and authorized disposci of the nuclear pacemaker by return to the manufacturer i

"D=lC L RECORD C01Y" Ml 3 4

she i be followed upon the death of the patient.

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_----_u-7 p!l RC Form 374A U.S. NUc _ R REIULATORY COMMISSION

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Licena n:Jnber MATERIALS LICENSE SNM-1969 l

SUPPLEMENTARY SHEET 070-03042 i

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SNM-1828 070-02876 l

l (Continued)

CONDITIONS l

15.

Except as specifically provided otherwise in this license, the licensee shall I

conduct its program in accordance with the statements, representations, and I

procedures contained in the documents including any enclosures, listed below.

I The Nuclear Regulatory Commission's regulations shall govern unless the state-I ments, representations and procedures in the licensee's application and corre-l spondence are more restrictive than the regulations.

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Application dated May 20, 1986 I

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