ML20210T629

Matls Licensing Package for Amend 7 to License SNM-1365 for Dept of Veterans Affairs.Control:466491

ML20210T629
Person / Time
Site:	07001401
Issue date:	08/15/1997
From:	Campbell V NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV)
To:
References
466491, NUDOCS 9709160012
Download: ML20210T629 (7)

Text

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N MATERIALS LICENSE oockei or nererence Number gl ll SUPPLEMENTARY SHEET 070-01401 gl N

N , Amendment No. 07 E

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E Department of Veterans Affairs North Texas Health Care System lg.

4300 South Lancarter Road Dallas, Texas 75216 5

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E In accordance with letter dated August 5,1997, Licens'e No SNM-1365 is hereby I y terminated. s - i N .

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E FOR THE U f NUCLEAR REGULATORY COMMISSION l B E N E g

l Date AUG l 51997 gy Ak , .

Vivian H. Campbell SR' Radiation Specialist l g,

h- Nuclear Materials Licensing Branch g Region IV p y Arlington, Texas 76011 j 9709160012 970815 PDR C

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1. 8 880 %g UNITED STATES NUCLEAR REGULATORY COMMISSION g ,. \ ' ',i )k _ REcloN IV SN- f 611 RYAN PLAZA DRIVE, SUlTE 400

• +n / ARLINGTON, TEXAS 760118064 August 15,1997 Department of Veterans Affairs North Texas Health Care System

, ATTN: Alan G. Harper, Director 4300 South Lancaster Road l Dallas, Texas 75216

SUBJECT:

TERMINATION OF YOUR NRC RADIOACTIVE MATERIALS LICENSE On August 5,1997, you contacted the U.S. Nuclear Regulatory Commission and indicated that you wished to terminate your NRC radioactive materials license. The NRC staff has reviewed '

the transfer record and acknowledgement of receipt by Medtronic, the manufacturer. Based on its review, the staff has concluded that alllicensable radioactive material has been removed from your facility and no residual radioactive material attributable to licensed activities exits at your current location.

Based on these conclusions no further remediation or actions with respect to NRC regulated material is required. Your facility is suitable for unrestricted use and NRC license number SNM 1365 for your facility at 4500 South Lancaster Road, Dallas, Texas is hereby terminated.

If you have questi<,ns or require clarification on any of the information stated above, we encourage you te contact us at 817-860-8143.

Sincerely, f

4 //

4(t Vivian H. Campbell f" ,

Senior Radiation Specialist Nuclear Materials Licensing Branch Docket: 070-01401 License: OWM 1365 Control: 466491

Enclosures:

As stated

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i Department of Veterans Affairs -4 Materials License Termination / Retirement Form j LICENSE #: SNM-1365 DOCKET #: 070 01401 LICENSEE: Department of Veterans EXPIRATION DATE: January 31,2005 Affairs DAT2 OF CONTACT: August 5,1997 North Texas Health Care CONTACTED BY: Alan G. Harper System TITLE: Medical Center Director i 4300 South Lancaster Road TELEPHONE: 214 376-5451 l ADDRESS: Dallas, Texas 75216 LICENSE TERMINATED: X LICENSE TRANSFERRED:

LICENSE TRANSFERRED TO: NAME:

ADDRESS:

TELEPHONE:

BASIS FOR TERMINATION AND/OR RETIREMENT: Review of receipt records for manufacturer, Medtronic.

TERMINATION DOCUMENTATION

1. License termination meets Type I criteria: Y X N Licensee used sealed sources only and the most recent leak test demonstrates that they did not leak while in the licensee's possession Licensee used radioactive material with Tg s 60 days and it has decayed to less than the activity in 10 CFR Part 20, Appendix C

2. License termination meets type 11 criteria: Y N Licensee possessed and used only seaNi sources but cannot demonstrate that the sources did not leak while in the licensee's possession Licensee possessed unsealed radioactive material with Ts s 60 days but the maximum activity authorized under the license has not decayed to less than the quantity specified in 10 CFR Part 20, Appendix C Licensee possessed unsealed radioactive material with T3 > 60 days but s 120 days Licensee possessed "C or 'H but the total activity and use authorized under the license warrants decommissioning under Type ll (describe rationale above)

Department of Veterans Affairs 5-

3. License termination meets Type ill criteria: Y N Decommissioning qualifies for a categorical exclusion under 10 CFR 51.22(c) and

- Licensee will decommission its facility in accordance with the NRC's criteria for unrestricted use l 4. License termination meets Type IV criteria: Y N l

Decommissioning does not qualify for a categorical exclusion under 10 CFR 51.22(c)

Licensee will decommission its facility such that residual radioactive material may remain in excess of NRC's criteria for unrestricted use

5. Termination survey required: Y N Termination survey submitted f licensee Termination survey satisfies NRC survey requirements

6. Form 314 or equivalent submitted: Y X N X Staff verified disposition of sealed sources or unsealed radioactive material by:

X letter from Form 314 recipient (Medtronic, manufacturer) call to Form 314 recipient

7. Licensee transfer records discussed in 10 CFR Parts 30.35, 30.36, 30.51; 40.36, 40.42, 40.61; or 70.25, 70.38, 70.51 Y N _NA to USNRC To individual assuming responsibility for the license, with a copy of the cover letter to NRC

8. NRC closeout inspection required: Y N _X Closeout inspection performed:

on:

-Inspector;

9. Closecut survey performed: Y N X on:

by:

Licensing staff completing form: Vivian H. Campbell

<b Date: 8/15/97 t/

Branch Chief: Date:

AUG I 51997 Department of Veterans Affairs i l

DOCUMENT NAME: L:\ TERM 97\SNM-1365.T To receive copy of document. Indicate in box:"C" = Copy without enclosures "E" = Copy with enclosures "N" = No copy RIV:NMLB li RIV:

VHCampbell k'h

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l k /15/97 OFFICIAL RECORD COPY

DEPARTMENT OF VETERANS AFFAIRS

@ North Texas Health Care System E~=j '

l In Reply Refer To:

August 5,1997 549/l]Q Jacqueline D. Cook, Health Physicist Nuclear Materials Licensing Branch _ . _

U.S. Nuclear Regulatory Commission, Region IV y~ j( p q, g 7i

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611 Ryan Plaza Dr., Suite 400 Arlington, TX 76011-8064

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Od! NM l 3lE b. i, REF: Docket No. 070-01401 TZR LicenseNo SNM 1365 i- ilb  !

Please terminate the above referenced nuclear pacemaker license. The only pacemaker which was being tracked has been explanted and returned to the manufacturer. Evidence of such transfer is enclosed. Please direct any questions to Mr. John Lowe, Radiation Safety Officer, at (214) 376-5451, extension 5040.

Alan G. Harper Director VA North Texas Health Care System cc: Director, Health Physics Programs (115HP)

VAMC St. Louis 915 N Grand Boulevard St, Louis, MO 63106 Dallas Veterans Aff airs Medical Center Fort Worth Outpatient Clinic Sarn Rayburn Memonal Veterans Center 4500 South Lancaster Road 300 West Rosedale 1201 East Ninth Street Dallas, TX 75216 Fort Worth, TX 76104 Bonham TX 75418 Corporate Of fice: 4500 South Lancaster Road, Dallas, TX 75216 g 4gg4g1

, . _ _ _ . - . . _ . _ - - = _ _ . _ . _ . . _ . _ _ _ _ . - _ _ . . . - . ___.=._._.m.. .m _

I Modtronic, tnc.

k E l*0 -7000 Central Avenue. N E.

. July 22,1997 Minneapoks, MN 55432 3576 =

Telephone:(612) 574 4000 4

Carlos Roman, M.D.

Med Ctr - Tower I, Ste 909

_ 7950 Floyd Curl Dr 2

San Antonio TX 78229

. RE: Patient: W Trammell Report: 670806

Implant Date

10/403 Explant Date: Unknown

Dear Dr1 Roman:

Medtronic appreciates the return of explanted pacing systems and any reported experience. The data obtained from the analysis is used to improve product reliability and develop an accurate performance index. Test results are provided below.

Generatur Model 9000 - SerialNumber 3R001$5 e Reasonfor return / report: No information.

Summan offindings: Testing of the pulse generator determined it was functioning normally.

LeadModel-SerialNumber 05430E2

• Non Medtronic device : Returned to the manufacturer, As no performance data was received with these devices, any clinical information you can provide will help us complete our file.

Medtronic is dedicated to providing high quality in technology and service. If you have further concerns or would like a detailed report of the analysis, please contact me at the number below or Bill Hickey, your Medtronic Representative, at (817)335-4420.

' Sincerely, MEDTRONIC, INC.

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Jan[e Crimmins Flynn c --~

Consumer Affairs Consultant u u; -

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800/328 2518(x3454)

Fax #: 6!2/574 3944 \\h'ki

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cc: John Boswell 40-14-00 - '/ i ^.-

John Lowe, VA Medical Center /

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