ML20147H316

From kanterella
Jump to navigation Jump to search
Application for Renewal of License SNM-1735,requesting Authorization to Follow Patients W/Implanted Pacemakers,Not for Implantation or Reimplantation & Adding Listed Names
ML20147H316
Person / Time
Site: 07002580
Issue date: 05/06/1987
From: Fletcher J, Ziegenhorn D
VETERANS ADMIN. MEDICAL CENTER, CINCINNATI, OH, VETERANS ADMIN. MEDICAL CENTER, WASHINGTON, DC
To:
NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
Shared Package
ML20147H261 List:
References
83527, NUDOCS 8803080453
Download: ML20147H316 (7)


Text

'

f.

Medical Center 3200 Vin) Street Cincinniti OH 45220 M Veterans

%Ed Administration in Reply Refer To:

539/115 United States Nuclear Regulatory Commission Region III 799 Roosevelt Road Glen Ellyn, IL 60137 Gentlemen:

The following respc,nse is pursuant to renewal of the Nuclear Powered Pacemaker License. Our NRC license number is SNM-1735 and our program code number is 22160.

(a) License Number:

SNM-1735 Expiration Date: May 31, 1987 Program Code:

22160 (b) Veterans Administration Medical Center 3200 Vine Street Cincinnati, Ohio 45220 s

(c) Two pacemakers have been authorized, NRC nusber SNM-1735 reference number 070-02580 (not to exceed 210 milligrams each). Both are Medtronic Model 9000 Nuclear Powered Pacemakers.

One remains implanted; the other was removed and returned to Medtronics on 9-18-86.

(See enclosed sheet)

(d) We are requesting authorization to follow the patients with implanted pacemakers, not for implantation or reimplantation.

(e) Pleame add the following physicians who are involved in the pacemaker program:

1.

Jon Rogers, M.D.,

Staff Cardiologist 2.

Yitzchak Hermoni, M.D., Staff Cardiologist (See enclosed information)

Sincerely, r

.p Y

lh 6'YM' aJNALD L. ZIEGENHO

/

MedicalCenterDir)ector

Enclosures:

2 gy g

  • Meddne Service (115) seosoe0453 000217 em Am%

3 70 WM M 2H2O PDR "America is #1-Thanks to our Veterans"

<1

'ef

.I

-f A.J

- V]

/

)

Y

_-.u._

_-.--..-.-w

. _. ~.,. _..

t.

..,......_.,q...

i..

z MedtronicR -

-).

PFjDUCT EVALUATION REPORT r

R

~

v.,,-

Instructions. Use thes form to report your espenence with a Medtronic product or when returning a device for s

analys:s. This information is necessary and wal espe $te processing for warranty consideratron.

4/

. k, finse ind4cate inodel and senal numbers oi the device (s) invotved: " Lead (s)

Model Noi ~'

Serial No.:

f Pulse cenerator'

  • -" " " ~

~~

~

~

~

.-;]

y, a

~

Model Not, 3 Sersal N. :

Model No.:

Serial Nol T'

9 i1

'V go oo -

ch oo w7 GENERAL INFORMATION x

h Physician.

h b

Hospital h

i

.f Pttesnt Name Street Address

, d u.,

1;,

~; w q,

oite of implant.; _

Date of Exp n t, City Stat Zip -

$ p

.t v i '

.M i.h cf J.-

g

' Q:[ f g Mp([,

[

sp-

-y 7

,*U l

Ns -?As y, Mfg. i g.;.fj i 6. M ;a CLINICAL INFORMATION y.dh. J c., w, y. s a.?;1 v g W ; e sf4fe:A s

N OTE: Piesee include all pertinent medical records including EK O's.1 M;'.

4 f

M

' D_.} E ective eplacemen d M.Of.Batryry oepietion N,., '.

, ~

+

{

o'nlapture -

' r. [ W

':. k Po'sitroning oirr cui g' yn. <

c.,,s-,

Ceported Esperience: 3 ;

-,,a,,

~.

.7

+

ix s

g-t r

^

' Myj-

.k 1

O'l'

- ~~ '

. ;. oversensing,.

(

"g paiieniE,p,rs :- u.

,<,'t

Rat change 4

bpm:.

I. Undersensing -

g:-

.: v. -

...c 4

new qsp' y c.

o s wigh rhresnoid., g

- k d ay'etgn'j pg g_ g

O ~ rme$ :M7 ~ '

  1. 1Q

' b'pm to A'* d'a9

. 0; Erosion y 4 -g

. No outpui-

. O, program,m;ng o,tricuity D: Sw mg * ~ ;

N.-b, y

y g

t 2 O g Oiner'(iiiease e,piainj:w..

- visuaiirreguientyi-

t4

~

g 1

,qm

^

q. g, y a-e

[

j

, :y

.; g h.y r. s-A -

o.4

r. U,3 e

s.

I }

\\ ""

  • J 5

n i /

1

  • e g

i

, r.t,@Mj. 4i

'1 e

- 2

/f A

Reported espenence ML-QW m a-

.A

.N

. f. <.

Pacing Modec.... O ooo? d wr y 'O'ovi

.'- Y :.f;.,'.

?.

MUL v4

'-. wts observed:- n #% 4 43

  • Contitivously A clntermittently% # P while emplantet t y@, p w e

(

o

,9 Programmed Parameters While implanted:

- $T-

}f Putu magnitude:

posts) Pulse Width:

Pulse interval (Rate);

,4

- I Sensstmty:

Refractory:

A.V interval:

a g,

'kl O Reused - O R,pa,,,d O unipotanzes deniaced O Capped Repos,tioned REPLACEMENT INFORMATION

'i if repla:ed. ind:cate replacement cemet$s 'J2 o 2 7219/ ead(s) 4 PG 2

'd.

I Serja[i 40..00 7 [>.?/O Y L

Mode 1 No.

l M

ruin cineraior

'[

Model No :

Senat No Modet No.:

SenalNo:

J W22.

FOLLOW-UP tNFORMATION 4

],[

Plaats ir'd:cate the riame. address and chone number.of the person to receive foHow-up information-

,,,v e

name

4 Area Code Pnorte 3

N,

.$/q jf MC O, 1

Address City -

t 2'D

/ e k ///9 7 &

Sthte/.

if you have a compladt. please specify:

t

.e 3

//.

ff //

b f, /?'

'f/-O */ gf E.aivate R* port comp.e:ed t>y.

t Om f 199214.101 1 WMe44edNoroc Veiton-CustW er Med Fm 2261 Oct 85

Pf g.

. ty

  • f 4

MedtronicE PLIDUCT EVALUATION REPORT instructions use this form to report your expenence wth a Medtron+c product or when retu anatysis This information as necessary and wilexpe$te processing foe warranty cons Please endicate model and serial numbers o' the devce(s)invotved f

Lead (s) Model No.:

Pu2se Generator Senal No.:

j Model No.:

SenalNo:

9000 C R OO K I T Model No.:

i Serial No.:

GENERAL INFORMATION Pnysic.anM,

/?RAAY 0 V4.

l Hospital

-l Pat.ent Name l

a Street Address I

cafe of Imptant Date of Cup nt l ),.

City i

4 State Zip

[

T 2

.- V $1/V() ?OY (f

1 CLINICAL INFORMATICN

/

l NOTE Please include all pertinent rnedical records including EKO's.

}

RIported Emperience:

.O Eiece,ve Regiacemeni O satiery oepietion doncapture O pai,en E,p. red O pos,i,on,ng o,rr,cutir O nate change O o,ersensing O

O n,,,ci,on.

N; a f,gnTnresnoid j

O opm io opr,i O undersensing

  • jl,{',,

E,oston O No outpui O p,ogramming citi,cuity O

C Otner (please espiain):

O visuaiirreguiarity:

Swi u,%

\\

\\

I Reported emperience., /

f was observed:

<. D..coninvousry t

Pacing Mode.

- Intermittentiy on.i mpianted:

O ooo O vvi/ O ovi O -

5,..-

l Programmed Parameters Wnile implanted:

Puise maynstude:

_ tvoits) Pulse Widtn:

Pulse intervai (Rate);

Sens4tmty-Refractory:

A V Interval:

I LCad Status:

O Reus,d O nepa, red O uniporan,ea O Repos,iioned O Rey, aced O capped

/

REPLACE MENT INFORMATION of replaces, in$icate rep:aceiner11 der.cets i

2O2 72N ~ Lead (s),4f[>2-b,

[A[ O,') [ b,$ O Mocel No :

Pulst Generator Sc reat fio :

Mocei No,

Serist No -

Model No :

I Serial No :

1 FOL L OW-UP IN FOR M ATION Picase ers cate the name. address and phone nunber of the eenson to receive fo!!ow.vo informat on Name i

h,

[ {q{/$l$ Ds Area Code Phone

,s Addetss City l

/ ? k M9 Y W Sht te/g Zip I

it you nave a compus'i.p; ease spees.

r i

i. g e ',.3 E..Pc.t c(mpg it31 t.y

.p 3

l-ff / ll l l,

i Date j/

p' u,ciou l

~ ^

v...
  • v. m.v m n o.. no,.

x

' Medical Center 3200 Vine Street

. Cincinnitl OH 45220 NA Wterans

%E# Administration April'29, 1987 in Reply Refer To:

f l

^

I'have read the Nuclear Pacemaker Protocol approved by the Nuclear Regulatory Committee, and agree to follow this protocol concerning this patient.

m h%lv Jon Roger Date v

"America is Mi-Thanks to our Veterans"

c d.:

1 R

' 1. Name Jon'N.: Rogers, M.D.-

2. Address.

1 Cincinnati,V.A.-Medical Center.

Division of Cardiology.

.3200 Vine Street

~

Cincinnati, Ohio 45220-

-3. Telephone number 861-3100 Extension'5072'(pager number 287)

4. License-Ohio 043831
5. Board 1);American Board _of Internal' Medicine:

(Specialty _-Internal Medicine)

2) American Board of. Internal'Medicit.e.

.(Subspecialty-Cardiovascular Disease).

.6. Position : at':V. A.~

. Staff Cardiologist.

'7. Previous Experience

~

with pacemakers Pacemaker Clinic at the Cincinnati VAMC.

July,'1984 to present

^

l' i

f i

i w_

(;,

(; s,,..

Medical Center -

3200 Vina Street Cincinruti OH 45220 M Veterans

%f=7 Administration April 21, 1987 In Reply Refer To:

s I have read the Nuclear Pacemaker Protocol approved by the Nuclear Regulatory Committee, and agree to follow this protocol concerning this patient.

f t

f A!h@Q' + 040 i

Il11I]

ld L

l_

tzchak Hermoni, M.D.

Date l

V I

l Y

f l

l l

[

+

"America is #1-Thanks to our Veterans"

1. Name Yitzchak Hermoni
2. Office Address Cincinnati V.A. Medical Center Division of Cardiology 3200 Vine Street Cincinnati, Ohio 45220
3. Telephone Number 861-3100 Extension 5072 (pager number 273) 3
4. License OHIO 49869 Marylar.d D28448
5. Board
1) American Board of Internal Medicine (Specialty-Internal Medicine)
2) American Board of Internal Medicine (Subspecialty-cardiovascular discaae)
6. Position at V.A.

Staff Cardiologist

7. Previous Experience with pacemakers Pacemaker Clinic at the Cincinnati VAMC July, 1980 to present,
    • 2 83527, 1

>