ML20147H258
| ML20147H258 | |
| Person / Time | |
|---|---|
| Site: | 07002580 |
| Issue date: | 02/17/1988 |
| From: | Vacherlon P NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| To: | |
| Shared Package | |
| ML20147H261 | List: |
| References | |
| NUDOCS 8803080434 | |
| Download: ML20147H258 (4) | |
Text
_ - _ _ _ _ _ _
yl===---------------A---------------------------------y l NRc Form 374 1
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PAGE OF PAGES l(s84)
U.S. NUCLEAR REcULATORY COMMISSION MATERIALS LICENSE Amendment No. 03
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l Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorga'nizatio'n Act of 1974 (Public Law 93-438), and Title 10, j
Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations y
1 heretofore made by the licensee, a license is hereby !ssued authorizing the licensee to receive, acquire, possess, and transfer byproduct, t
1 source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below;to r
1 deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This E
I license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amanded, and is
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subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any j
conditions specified below.
In accordance with letter received j
May 8, 1987 h
j Veterans Administration Medical Center
- 3. Ucense number SNM-1735 is amended in k
1-1 its entirety to read as follows:
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3200 Vine Street l l t,
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Cincinnati, OH 45220 yF
- 4. Expiration date February 28, 1993 l l s
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-*1 y 070-02580
- 5. Docket or l
Reference No.
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ll 6. Byproduct, source,and/or/
- 7. Chemical and/or physical V8. Maximum amount that licensee 9
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A. Plutonium (Principal
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A;,.21 grams (1 source j
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As a component of MedtronicModel'9000 nEc1le'arlpowered pacemakers for clinical
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purposes of explantation,~ recovery and disposalc but not for;these pacemakers for 3
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reimplantation.
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CONDITIONS 4/
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- 10. Licensed material shall be'ured only at VeteransiAdministration Medical Center, q
1 3200 Vine Street, Cincinnati, Ohio..
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The specified possession limit includes all licensed material possessed by the 1
licensee under this license whether in storage, implanted in patients or otherwise in use.
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- 12. The licensee shall not receive or transfer in any single transaction, 1 gram or more 1
1 of plutonium-238 contained in nuclear-powered pacemakers without notifying the 1
1 Division of Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, l
l and, in addition, completing and distributing Form NRC-741 as required by Section l
]i 70.54 of 10 CFR Part 70.
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- 13. The licensee shall report to the Material Licensing Section, U.S. Nuclear Regulatory L
jl Cormiission, 799 Roosevelt Road, Glen Ellyn, Illinois 60137 within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of 4i 1l occurrence, the death of any nuclear pacemaker patient, and any adverse reaction l
11 and/or malfunction involving a pacemaker system, including the leads. A written l
I report giving details of the adverse reaction and/or malfunction shall be submitted l
within 30 days.
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l NRC Form 3MA U.S. NUCLE AT! r.E;ULATcRY COMMISSION 2
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l MATERIALS LICENSE
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CUPPLEMENTARY SHEET 070-02580 i
i Amendment No. 03 p
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The licensee shall report to the Material Licensing Section, U.S. Nuclear "gulatory l
l Commission, 799 Roosevelt Road, Glen Ellyn, Illinois 60137 within 10 days, loss of M
4 contact with a nuclear pacemaker patient.
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15.
The licensee shall continue patient follow-up and replacement procedures for the l
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nuclear pacemaker during the life of the patient; and the procedures for recovery yi g
and authorized disposal of the nuclear pacemaker by return to the manufacturer shall 4
be followed upon the death of the patient.
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16.
Except as specifically provided otherwise in this license, the licensee shall l
conduct its program in accordance with the statements, represent tions, and g
procedures contained in the documents including any enclosurcs, listed below, q
The Nuclear Regulatory Comission's regulations'shall. govern unless the statements, N
representations and procedures in the licensee's application and correspondence are j
more restrictive than the regulations.
l A.
Letters dated April, 22, 1977, May 19, 1978 and April 14, 1982; and 4
4 B.
Letter receiv,ed May 8, 1987.
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l Date: February 17, 1988 By Patricia M. Vacherlon 1'
Materials Licensing Section, Region III l
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PAGE OF PAGES
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y (b84 U.S. NUCLET.R REGULATORY COMMISSION.
MATERIALS LICENSE Amendment No. 03 l
l 1
l Pursuant o the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438), and Title 10, g
Code of Federal Regulations, Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations y
l heretofore made by the licensee, a license is hereby issued authorizing the licerece to receive, acquire, possess, and transfer byproduct,~
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source, and special nuclear material designated below; to use such material for the purpose (s) and at the place (s) designated below;to l
I deliver or transfer such material to persons authorized to receive it in accordance with the regu:ations of the applicable Pargs). This l
N license shall be deemed to contain the conditions specified in Section 183 of the Atomic Energy Act of 1954, as amedded, and is I
l subject to all applicable rules, regulations and orders of the Nuclear Regulatory Commission now or hereafter in effect and to any y
conditions specified below.
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I Licensee In accordance w.th letter received i
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N May 8, 1987 il l-Veterans Administration Medical Center
- 3. Ucense number SNM-1735 is amended in j
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its entirety to read as follows:
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3200 Vine Street 8
- 4. Eipkr?ti February 28, 1993 j
Cincinnati, OH 45220 h
- 5. Docket or N
A 070-02580 y
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Reference No.
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- 6. Byproduct, source, and/or
- 7. Chemical and/or physical L Maximum amount that licensee I
I special nuclear material form
,ay possess at any one time 1
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under this license
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A. Plutonium (Principa.1 Sealed. Sources
.21 grams (1 source radionuclide Pu-238)*
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not to exceed 210 l
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- 9. Authorized Use i
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As a component of Medtron E'Hodel 9000 nuc ear-powered pacema,fers for clinical g
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- 10. Licensed material shall be used1only, at Veteranst Admi istration Medical Center, h
3200 Vine Street, Cincinnati, Ohio: s e A P a
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- 11. The specified possession limit includes all licensed material possessed by the p
licensee under this license whether in storage, implanted in patients or otherwise
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in use.
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- 12. The licensee shall not receive or transfer in any single transaction, 1 gram or more g
of plutonium-238 contained in nuclear-powered pacemckers without notifying the R
Division of Safeguards, U.S. Nuclear Regulatory Commission, Washington, D.C. 20555, H
and, in addition, completing and distributing Form NRC-741 as required by Section l
l 70.54 of 10 CFR Part 70.
l l
- 13. The licensee shall report to the Material Licensing Section, U.S. Nuclear Regulatory q
Commission, 799 Roosevelt Road, Glen Ellyn, Illinois 60137 within 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> of ly lh g
occurrence, the death of any nuclear pacemaker patient, and any adverse reaction p
4 and/or malfunction involving a pacemaker system, including the leads. A written I
report giving details of the adverse reaction and/or malfunction shall be submitted
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MATERIALS LICENSE f
SUPPLEMENTARY SHEET 0 -02580 4
d Amendment No. 03 p
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- 14. The licensee shall report to the Material Licensing Section, U.S. Nuclear Regulatory p
i Commission, 799 Roosevelt Road, Glen Ellyn, Illinois 60137 within 10 days, loss of n
4 contact with a nuclear pacemaker patient.
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- 15. The licensee shall continue patient follow-up and replacement procedures for the l
l nuclear pacemaker during the life of the patient; and the procedures for recovery p
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and authorized disposal of the nuclear pacemaker by return to the manufacturer shall
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W be followed upon the death of the patient.
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- 16. Except as specifically provided otherwise in this license, the licensee shall E
l conduct its program in accordance with therstatements, representations, and q
procedures contained in the documentis incliding['any enclosures, listed below.
l The Nuclear Regulatory Co,mmissio'n's regulations shall, govern unless the statements, p
$q representations and procedures in the licensee's applicat, ion and correspondence are N
5 more restrictive than the regulations.
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Letters dated Pil 22, 1977, May 19, 1978 and Apri,1 'l 1982; and l
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4j For the U.S. Nuclear Regulatory Commission 4
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fDate: February 17, 1988 By Patricia M. Vacherlon f
Materials Licensing Section, Region III
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