ML20128E091
| ML20128E091 | |
| Person / Time | |
|---|---|
| Site: | 07003019 |
| Issue date: | 05/30/1985 |
| From: | Wright E NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION II) |
| To: | |
| Shared Package | |
| ML20128E094 | List: |
| References | |
| NUDOCS 8507050255 | |
| Download: ML20128E091 (2) | |
Text
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NRC For,* 274 NE y OF p PACES t
(a sa) U.S.NUCLSAR RE!ULAToRY COMMISSloN MATERIALS LICENSE Pursuant to the Atomic Energy Act of 1954, as amended, the Energy Reorganization Act of 1974 (Public Law 93-438).and Title 10, Code of Federal Regulations. Chapter I, Parts 30,31,32,33,34,35,40 and 70, and in reliance on statements and representations 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 deliver or transfer such material to persons authorized to receive it in accordance with the regulations of the applicable Part(s). This 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 conditions specified below.
-I Licensee
- 1. Ponce District Hospital 3. License number SNM-1951 2' Machuelo Road 14 .
- Ponce, Puerto Rico 00731 3 4. Expiration date Mav 31. 1990
.s 5. Docket or . SNi4-1363 s Reference No. 070-01336/070-03019
- 6. Byproduct, source, and/or me
- 7. Chemica' and/or physical *
. 8. Maximum amount that licensee
- special nuclear material form 'may possess at any one time
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under this license
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A. Plutonium (Principal, A. Sealed source
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radionuclide Pu-238), cin cardiac. pacemaker exceed 150 milligrams I 5.. '"". [Q.
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Cg m (2.5' curies in 1972) j
- 9. Authorized use -
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A. Implantation in humans asla6 component of1Medtronic~ Model 9000 nuclea'r powered j
!. cardiac pacemaker for clinical. evaluation. ~(Note:' The device is already implanted i
in a patient. This license is for patient follow-up.)
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"/ CONDITIONS .
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- 10. Licensed material shall be used only at' Ponce District Hospital, Machuelo Road 14, Ponce, Puerto Rico.
- 11. The licensee shall comply with the provisions of Title 10, Chapter 1, Code of Federal. Regulations, Part 19, " Notices, Instructions and Reports to Workers; Inspections" and Part 20, " Standards for Protection Against Radiation."
- 12. The specified possession limit includes all licensed material possessed by the licensee under this license whether in storage, implanted in patients or other-wise in use.
- 13. The licensee shall not receive or transfer ir, any single transaction one (1) gram or more of plutonium 238 contained in nuclear powered pacemakers without i: notifying the Division of Safeguards, U.S. Nuclear Regulatory Commission,
.[ Washington, D.C. 20555, and, in addition, completing and distributing Form
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7-- *------------ammmmmmmmwwmmmmmmmwamumw----m_m,-mmmm my j C Form 372A U.S. NUCLEAR REGULATORY CoMMISSloN PACE 2 or 2 1 License nurnber Paces y)
MATERIALS LICENSE SNM-1363
- '*"**""'" l 1 SUPPLEMENTARY SHEET 070-01336 l
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l (cont'd) CONDITIONS d
1 1 14. The licensee shall report to the Material Licensing Branch, U.S. Nuclear ;
d Regulatory Commission, Division of Fuel Cycle and Material Safety, Washington, i j D. C. 20555, within twenty-four (24) hours of occurrence, the death of any 3
nuclear pacemaker patient, and any adverse reaction and/or malfunction involving g y a pacemaker system, including the leads. A written report giving details of the g; j adverse reaction and/or malfunction shall,be submitted within thirty (30) days.
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- - . g, 1 15. The licensee shall report to 'th'e Material ^ Licensing Branch, Division of Fuel El 1 Cycle and Material Safety, U.S. Nuclear Regulatory ; Commission, Washington, E l D . C ., 20555, within te,n (10) days, loss of contact ' ith w a nuclear pacemaker lg 3
patient.
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1 16. The licensee shall continue. patient follow-up and replacement procedures for the g.
H nuclear pacemaker during the . life of the patient. ,, Procedures for recovery and 1, 3 authorized disposal :of the nuclear pacemaker by return to the. manufacturer shall EL be followed upon the death of the patienth l . , ,
l1 3 17. Except as speci.fically provide'd(oth.erwise by. this license the licensee g' d shall possess and* use licensed , material described in' Items 6, 7, and 8 of g M this license in . accordanc'e with~ statements,cr'epresentations;" and procedures E 3 listed below. The Nucleari Regulatory: Commission's regulations shall govern lEl lg the licensee's statements:'in;(applications .or l etters', unless the statements f f
are more restrictive than theiregulations.q Q g j -
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g A. Application (s) dated: )i lg!
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ig Hi (1) April 25, 1985 signed Evelyn Cintron Ruiz, M.Dt' lE:
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3 (2) Application enclosed with letter dated 0,ctober 6, 1972.
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Iy jl B. Letter (s) and attachments thereth_ddle.d:4 g I
1 E 3l (1) May 29, 1973 signed Mr. Angel Franceschi k 1 May 29, 1973 signed Dr. Rodriguez E
% October 6, 1972 signed Dr. Hector F. Rodriguez E 2 ~
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1 E 1 e 1 E 3 k 1 FOR THE U.S. NUCLEAR REGULATORY COMMISSION E.
1 E l EARL G. WRIGHT, . E 4
Date By 2 , f 1 Region II, Nuclear Materidls .
!g 1 Safety Section E 1 101 Marietta Street, Suite 2900 )
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Atlanta, GA 30323
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