ML20128J084

Matls Licensing Package for Amend 8 to License SNM-1969 for VA Medical Ctr in Brooklyn.Control:123608

ML20128J084
Person / Time
Site:	07003042
Issue date:	09/24/1996
From:	Michelle Beardsley NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
To:
References
123608, NUDOCS 9610100179
Download: ML20128J084 (11)

Text

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. 3. NUCLEAR REGULATORY COMMISSION OF _2 PAGES g 1

i g SI ATERI AI.S 1 lCENSE Amendment No. 08 g 5'

g y Pursuant to the Atonne I:nergy Act of 1954, as amended the linerg) Reorgani/ation Act of 1974 (Pubhe Law 90438L g Federal Regulations. Chapter 1. Parts 30. 31,32. 33. 34. 35. 36. 39. 40. and 70. and in reliance on statements and repres pl by the hcensee. a hcense is hereby iwued authori/ing the licensee to receise, acquire powew, and transfer material designated below; to use such material for the purposeta and at the place (u designated below; to deliser or transfer such g persons authori/ed to receise it in accordance with the regulations of the applicable Parttu. This beense shall be deemed to contain the conditionsI S} specified in Section IM3 of the Atomic Energy Act of 1954. as amended, and is subject to all apphcable rules, regulations, i an Sj Nuclear Regulatory Comnnwion now or hereaf ter in ef fect and to any condumns specified below. i Ib OFFICR MCORD COM '

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'El i El Licensee El In accordance with the letter dated i August 8, 1996, i l?j l. V. A. Medical Center in Brooklyn 3. License Number SNM-1969 is amended in i lEi its entirety to read as follows: 8 l 800 Poly Place i 2 2. Brooklyn, New York 11209 ly[i j; 4. Expiration Date June 30, 2001 i

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l Nr nc No. 070-03042/SNM-1828 A

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! 6. Hyproduct. Source, and/or Special Nuclear Material 7. Chemical and/or Ph> sical 8. Maximum Amount that Licensee E s! Form  :

i May Possess at Any One Time i Q l'nder This License

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l lA. Plutonium (principal A. Sealed source A. 210 milligrams 'i j , radionuclide Pu-238) i 2

n 9. Authorized use i e

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l lA. As a component of Medtronic Laurens-Alcate Model 9000 nuclear-powered cardiac pacemakers for clinical evaluation in accordance with manufacturer's protocol dated i

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! July 12, 1995, this authorization includes: follow-up, explanation, recovery g i

I disposal, but not implantation. e l l q

CONDITIONS dlJ iy Q ,

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l Licensed material may be used only at the licensee's facilities located at 800 Poly 's 2 Place, Brooklyn, New York and the Veterans Administration Hospital, Northport, Long Island, New York.

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y 11. The physician responsible for follow-up, explanation, and return of nuclear-powered  ;;

,9 1 al pacemaker to the manufacturer for proper disposal is Sina Zaim, M.D.

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e p 12. The Radiation Safety Officer for this license is Esfandiar Sarfaraz, M.D. j v

la 13. The specified possession limit for cardiac pacemakers includes all licensed material possessed by the licensee under this license whether in storage, implanted in @

g patients, or otherwise in use. p n

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h 14. The licensee shall continue patient follow-up and replacement procedures for the [

1 nuclear pacemaker during the life of the patient. Procedures for recovery and  ;-

f j authorized disposal of the nuclear pacemaker by return to the manufacturer shall be followed upon the death of the patient. '

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Sealed sources or detector cells containing licensed material shall not be opened or  ;

f sources removed from source holders by the licensee.

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AR REGULATORY COMMISSION g PAGE 2 OF 2 PAGES g! l LKense NumtF g g y SNM-1969 Ei MATERIALS LICENSE (Arket or Reference Number g g! l SUPPLEMENTARY SHEET d 070-03042/SNM-1828 El l M if Amendment No. 08 N

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The licensee is authorized to transport licensed material in accordance with the 1 g l provisions of 10 CFR Part 71, " Packaging and Transportation of Radioactive Material." g N

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Except as specifically provided otherwise in this license, the licensee shall conduct i l g

its program in accordance with the statements, representations, and procedures '

g contained in the documents, including any enclosures, listed below. The Nuclear  !

y y Regulatory Commission's regulations shall govern unless the statements, gi p i representations, and procedures in the licensee's application and correspondence are gf more restrictive than the regulations. g p

B y A. Application dated December 14, 1995 F B I i F

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SEP 2 41996 i[ l Mcholle Beardsley gl Date By Division of Nuclear Materials Safety

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O' O SEP 2 41996 Mr. Michael A. Sabo Medical Center Director Veterans Administration Medical Center 800 Poly Place Brooklyn, NY 11209

Dear Mr. Sabo:

This refers to your license amendment request. Enclosed with this letter is the amended license.

Please review the enclosed document carefully and be sure that you understand and fully implement all the conditions incorporated into the amended license.

If there are any errors or questions, please notify the U.S. Nuclear Regulatory Commission, Region I Office, Licensing Assistance Team, (610) 337-5093 or 5239, so that we can provide appropriate corrections and answers.

Thank you for your cooperation.

Sincerely, Original Signed By:

Michelle Beardsley Michelle Beardsley Division of Nuclear Materials Safety License No. SNM-1969 Docket No. 070-03042 i Control No. 123608 l

Enclosure:

Amendment No. 08 cc: Francis K. Herbig Department of Veterans Affairs Health Physics Programs (115HP) 915 North Grand Blvd.

St. Louis, M0 63106 DOCUMENT NAME: R:\WPS\MLTR\LSNM1969 To receive a copy of this document, indicate in the boa: "C" = Copy w/o attach /enci *E' = Copy w/ attach /enel "N" = No copy l I

OFFICE ' DNMS/RI N DNMS/RI /(f NAME Stambaugh/jvsQfd Beardsley/1,p (

09/24/96 ./ Jod/96 09/ty /96 '//

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DATE 09/ /96 09/ /96 l OFFICIAL RECORD COPY

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DEPARTMENT OF VETERANS AFFAIRS Medical Center 800 Poly Place Brooklyn NY 11209 AUG - 8 1996 in nesy sever im afoN U.S Nuclear Regulatory Commission Region I 475 Allendale Road King of Prussia, Pennsylvania 19406-1415 Thru: Deputy Director, Health Physics

Subject:

License No. SNM-1969 Docket NO. 070-03042

1. As per part 35, sections 35.13 and 35.14 of the U.S. Nuclear Reaulatorv Commission Rules and Reoulations. Title 10, Chapter 1, CFR-Energy, this letter

, serves to notify the Commission of the discontinuance of performance of duties of an authorized user on the above license, Praveer Jain M.D.

2. Upon your approval we are requesting that Sina Zaim M.D. serve as an authorized user on the above license. Attached please see his training and curriculum vitae.

3. If you require furtherinformation please contact the Radiation Safety Officer, Esfandiar Sarfaraz. Ph.D at (718) 836-6600, Ext. 6285

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i ichael .b O Medical Center Director Enclosure 123608 0FFICIAl. RECORD COPY. #L 10 AUG 261996

- . _ - . --_ . - . - - _ . . - _ = . __. -. . - .. . . . ~ . . - .

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DEPARTMENT OF VETERANS AFFAIRS Medical Center St Louis MO 63125 in Reply Refer To:

., , August 21,1996 U.S. Nuclear Regulatory Commission Region I 475 Allendale Rd.

King of Prussia, PA 19406-1415 l l

SUBJECT:

NRC License No. SNM-1969 f

The enclosed correspondence from the Brooklyn, New York VA Medical Center has been received and is forwarded to your office for processing. If there are questions, please contact the facility.  ;

Please provide a copy of any correspondence relative to licensing actions for this Medical Center to: .

l Department of Veterans Affairs ,

Health Physics Programs (115HP) i 915 North Grand Blvd. l St. Louis, MO 63106 j i

Sincerely, I O f dD W h  :

J Francis K. Herbig Health Physics Programs i

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CURRICULUM VITAE 1

! Sina ZAIM, M.D.

l Assistant Professor ofMedicine i SUNY - Stonybrook l 1

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Office Address: Division of Cardiology l'

j SUNY Health Sciences Center T-17 020

Stony Brook, NY 11794-8171

] , (516) 444-1060 beeper: 282-8780 i Home Address:

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• BiographicInformation: - .

Date of birth ,

Place ofBinh Marital Status S.S. Number ,

Nationality Education and Degrees:

1969 Morris Hills H.S., Rockaway, NJ (1965-68) Northern Collegiate, Sarnia, Canada 1973 B.A. Rutgers University, New Bmnswick, NJ (1971-72) University of Tours, Tours, France 1975 M.S. Rutgers University, Graduate School of Chemistry New Brunswick, NJ 1981 M.D. Cornell Medical College, New York, NY (1975-79) University of Lausanne Medical School Lausanne, Switzerland

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Graduate Medical Education: .

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Internship and Residencies:

i 1981-1982 Internin Medicine, ,

The Roosevelt Hospital -/

New York, NY 1982-1984 Resident in Medicine, The Roosevelt Hospital New York, NY l Research Fellowships: l

,1985-1986 Research Fellow in Clinical Pharmacology j

, Division of Cardiology ,

Columbia Presbyterian Medical Center .t..

New Yo'rk, NY [

1986-1987 Research Fellow in Pharmacology,

Division of Pharmacology, College ofPhysicians and Surgeons, Columbia University New York, NY ClinicalFellowships:

l 1984-1985 Fellow, Department of Critical Care Medicine, Memorial Sloan-Kettering Cancer Center ,

New York, NY l 1

1987-1989 Fellow, Division of Cardiology, SUNY Health Science Center at Brooklyn, Brooklyn, NY 1989-1991 Fellow, Cardiac Electrophysiology, The Massachusetts General Hospital,

/ Boston, MA

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Licensure and Certification: .

1982- New York Medical License l

1985- American Board ofInternal Medicine 1987- American Board ofInternal Medicine subspecialty Critical Care Medicine 1989 Massachusetts Medical License (inactive) 1989- American Board ofInternal Medicine subspecialty Cardiovascular Disease l

1991 Georgia Medical License (inactive) 1993- Pennsylvania Medical License -

1994- American Board ofInternal Medicine subspecialty Clinical Cardiac Electrophysiology Previous Faculty Appointments:

7.1991-6.1993 Assistant Professor of Medicine (Cardiology)

Emory University School ofMedicine Atlanta, GA ,

7.1993-8.1995 Assistant Professor of Medicine (Cardiology)

Hahnemann University Hospital Philadelphia, PA Research Interests:

Ventricular anhythmias Implantable Cardioverter De6brillators Principal Investigator (Emory Site): CPI Ventak P2 CPI Ventak P2/Endotak MADIT Principal Investigator (Hahnemann): MADIT DDD vs DDDR(Mt. Sinai, Miami)

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o.- o Bibliography:

Original Reports

1. Giardina EG,74m S, Saroff A, Kirschenbaum M. Indecainide compared with quinidine for chronic stable ventricular arrhythmias secondary to coronary artery disease or to cardiomyopathy. Am J Cardiol 1987;60:584-589.

2. Dangman KH, Dresdner KP, Zaim S. Automatic and tdggered impulse initiation in canine subepicardial ventricular muscle ce!!s from border zones of 24-hour transmural infarcts. New mechanism for malignant cardiac arrhythmiast Circulation 1988;78:1020-1030.

3.- Dangman KH, Zalm S, Miura DS. Local anesthetic and negative -

chronotropic gffects of diltiazem on canine cardiac Purkinje fibers. Am, Heart J 1989;l17:1271-1277.

4. Zaim S, Dangman KH. Cellular electrophysiology.and B- adrenergic '

blocking activity of dilevalol, the R, R-isomer oflabetalol, on isolated canine cardiac tissues. J Cardiovasc Pharmacol 1989;14:496-501.

5. Dangman KH, Zaim S, Hoffman BN, Hoffman BF. Electrophysiology of ethacizin: effects of arrhythmias in the in situ heart and transmembrane action potentials of Purkinje fibers and ventricular muscle fibers. J Cardiovascular Electrophysiology.1990;1:411-425.

Rankin AC, Zaim S, Powell A, Zaim B, Brooks R, McGovern B, Garan H, 6.

Ruskin JN. Efficacy of a tiered therapy defibrillator system for the treatment of recurrent dmg-refractory ventricular arrhythmias. British Heart Journal 1993;70:61-69.

7. Zaim S, Connolly M, Roman-Gonzales J, Walter P, Craver J, Jones E.

Perioperative complications of cardioverter-defibrillator implantation: The Emory Experience. The American Journal of the Medical Sciences.1994;307:185-189.

8. Zaim B, Zaim S, Rankin B, McGovern B A, Ruskin JN, Garan H.

Comparison of cycle lengths between electrically induced and spontaneous ventricular tachycardias during concordant antiarrhythmic therapy associated with  ;

healed myocardialinfarction. Am J Cardiol.1996;77:202-204.

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9. Zaim S, Zaim B, Rottman J, Pacifico A and the Cadence Investigators.

Nature of spontaneous tachyarrhythmias detected by electrogram storing defibrillators in sudden cardiac death survivors with no inducible ventricular tachyarrhythmias at baseline electrophysiologic testing. Circulation 1994;90:1-455.

i 10 Micklin A, Sheppard RC, Foley R, Hessen SE, Zaim S, Kravitz KD, Kutalek SP. Atrial synchronous versus AV sequential pacing for hypertrophic cardiomyopathy (HOCM).J AmCollCardiol 1995;25':10A.

I 1. Hessen SE, Pace JN, Kravitz KD, Zaim S, Kutalek SP. Prognosis of  !

patients after very frequent implantable cardioverter defibrillator shocks. PACE 1995;I8:1154. .

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12. Hessen SE, Samuels F, % S, Kutalek SP. Radiofrequency catheter ablation of symptomatic ventricular ectopy. PACE 1995; 18:1166. I

13. Zaim S, Zaim B, Rottman J, Mendoza I, Nasir N, Pacifico A and the -

Cadence Investigators. Sudden Cardiac Death survivors with only ventricular ,

fibrillation induction at baseline electrophysiologic testing: subsequent ventricular tachyarrhythmias. PACE 1995;18:1118 '

14. Venkar A, Kravitz K, Micklin A, Zaim S, Hessen SE, Kutalek SP, Ross J, Msysovitz C. Right ventricular dysfunction predicts early mortality in patients with intracardiac defibrillators. PACE 1996; '

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15. Zaim B, Williams J, Rottman K, Muelheims G, Zaim S. Long term i outcome following radiofrequency ablation of the atrioventricularjunction and permanent pacemaker implantation for dmg refractory atrial fibrillation or flutter. ,

European J of Cardiac Pacing and Electrophysiology 1996;6:297 l

16. Clay A, Dreifus LS, Zaim S, Kutalek S. Can dispersion of the QT interval .

identify inducible monomorphic vs polymorphic ventricular tachycardia. European I J cf Cardiac Pacing and Electrophysiology 1996;6: 364 17 Zaim S, Kwatra K, Kravitz K, Movsowitz C, Zaim B, Pace J, Sheppard RC, Kutalek SP. Mortality in defibrillator patients with decreased ventricular i function. European J of Cardiac Pacing and Electrophysiology 1996;6:1112 I

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i  : (FOR LFMS USE) l

INFORMATION FROM LTS BETWEEN: .

i LICENSE FEE M AN AGEMENT BRANCH, ARM  : PROGRAM CODE: 22160 AND  : STATUS CODE: 0 l REGIONAL LIC ENSING SECTIONS  : FEE CATEGORY: EX 7C  !

i  : EXP. DATE: 20010630 l  : FEE COMMENTS: PACEMAKER /REF 31-0289

)  : DECOM FIN ASSUR REQD: N LICENSE FEE TRANSMITT AL

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i A. REGION y

1. APPLICATION ATT ACHED A P PLIC A NT/ LIC E N S E E: V. A. MEDICAL CENTER R ECEIVED D ATE: 960326 DOCKET ND: 7003042

' CONTROL NO.: 123608 LICENSE NO.: SNM-1969 ACTION TYPE: AMENOMENT i,

2. FEE ATThCHED AMOUNT: ___ _____

CHECK NO.: _ ______

i

3. COMMENTS SIGNED __[Cb , 'd_;_____

DATE _________S _E2 fY________

B. LICENSE FEE MANAGEMENT BRANCH (CHECK WHEN MILE STONE 03 IS ENTE R ED / __/ )

1. FEE CATEGOR Y AND AMOUN T: _________________________________________

2. CORRECT FEE PAID. APPLICATION M AY BE PROCESSED FOR:

AMENOMENT ______________

RENEWAL ______________

LICENSE ______________

3 OTHER __________________________________

SIGNED _________________________________

DATE _________________________________

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