ML20147F616

Submits Addl Info Re Application for Renewal of License SNM-1735.Requests That Listed Physicians Be Authorized to Follow Patients W/Implanted Pacemakers

ML20147F616
Person / Time
Site:	07002580
Issue date:	04/24/1987
From:	Ziegenhorn D VETERANS ADMIN. MEDICAL CENTER, CINCINNATI, OH
To:	NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III)
Shared Package
ML20147F603	List: ML20147F599 ML20147F612 ML20147F616
References
84109, NUDOCS 8803070395
Download: ML20147F616 (12)

Text

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I Medical Center 3200 Vine Street Cincinnati OH 45220 M Veterans W /tdniinistration-April 24 1987 in Reply Refer Toi 115 United States Nuclear Regulatory Commission Region III 799 Roosevelt Road Glen Ellyn, IL 60137 Gentlemen:

The following response 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 3200 Vine Street Cincinnati, Ohio 45220 (c)

Two pa'cemakers have been authorized, NRC number SNM-1735 reference number 070-02580 (to not to exceed 210 milligrams each).

Both are Meotronic Model 9000 Nuclear Powered Pacemakers.

One rer.ains implanted, the other was removed and returned to Heotronics on 9-18-86.

(see attached sheet)

(d) We are requesting authorization to follow the patienth with implanted pacemakers,'not for implantation of reimplantation.

(e)

Please add the following physician's who are involved in the pacemaker progrim:

1.

Jon 'iogers, M.D. Staff Cardiologist 2.

Yitzchak Hermoni, M.D. Staff Cardiologist See attached information Donald L. Ziegenhorn Medical Center Director 09 CONTROL H0.B 41 khO G80302 SNM-1735 PDR

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1. Name.

'Jon.N.. Rogers, M.D.

2. Address'

-Cincinnati V.A. Medical Center Division of Cardiology 3200 Vine Street Cincinnati,;0hio 45220

3. Telephone number.

861-3100 Extension 5072 (pager number.287)

4. License Ohio'043831

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- 5. Board

1) American Board of Internal Medicine (Specialty-Internal Medicine);

2) American Board of Internal Medicine,

'(Subspecialty-Cardiovascular Disease)

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6. Position at'V.A.

Staff Cardiologist

7. Previous Experience with pacemakers Pacemaker Clinic at the Cincinnati VAMC July, 1984 to present I

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f Medical Center 3200 Vine Street Cincinnati OH 45220 -

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W Administration April 29, 1987 in Reply Refer To:

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

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g Jon Rogers, 21.D,.7 Date i

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1. Name-Yitzchak Hermoni s

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)

4. License

'0HIO 49869 Maryland D28448

5. Board-

1) American Board of Internal Medicine (Specialty-Internal Medicine)

2) American Board of Internal Medicine:

(Subspecialty-cardiovascular disease)

6. Position at V.A.

Staff Cardiologist

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

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.j-x Medical Center 3200 Vine Street

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e Cincinnati OH 45220 -

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%W Administration-April 21,-1987 in Reply Refer To:

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

concerning this patient.

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"Annnica is tR-Whenks to our l'rtemen"

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G X2 &een Memorandum o.te: April 21, 1987 F a om: Nuclear Medicine Service (115) to Yitzchak Hermoni, M.D.

sut,i: Radionuclide powered pacemakers Jon Rogers, M.D.

By Nuclear Regulatory Commission rule, we must have the list of physician's who are involved in our pacemaker program as we have discussed before.

I would be glad if both of you will abide by our request.

For our license, we must have the following information, we would appreciate it if you can return this information to us.

1.

Physicians name 2.

Office Address 3.

Telephone Number 4.

State in which licensed to practice medicine 5.

Specialty board cerification 6.

Position at V.A. Medical Center 7.

A short description of your previous experience with any pacemaker Also we attached a copy of NRC approved protocol, to which your signature is required.

I tnak you for your cooperation.

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Qh Hiroshi,' 'Nishiyama, M.D.

s Chairman, Radistion Saf y Committee Please Note: At present we have only 1 patient with a nuclear-powered pacemaker in this hospital. Another patient moved to Lexington some years back we have taken appropriate follow-up and we are officially off the hook.

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Medironic(si

%"c"NLne.nc Moreapo5s. MN 55432 USA December 3' 1986~~

mm m2:5744000 Cabie-Mesonc Telex. 29 0593 :

MarceloLBranco, M.D.

Re: -Gilbert Preston! (420758)

-VA Medical Center

,-Model:

9000 S/N:

5R00217 Cardiology Section-(111-B)

Lead mop l: 6901 S/N:

53661MC

. Cooper Drive Division ~

Implant: 08-09 Explant:

09-15-86 Lexington, KY 40506

Dear Dr. Branco:

J Thank you. for returning the referenced pulse generator and lead to Medtronic-for evaluation.

Noncapture was indicated as the reason for explant.

Your continued cooperation in returning pulse generators and leads for analysis is appreciated.

We invite your comments and recommendations on our products and services.

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Our Product Analysis Laboratory has completed their analysis of this generator and have found it to be functioning within specifications.

The unit was initially tested as received.

The following parameters were recorded during

-the preliminary testing of the device:

PULSE PAGNITUDE:

5.09 volts PULSE DURATION:

1.076 msec PUI.SE INTERVAL (RATE):-

856 msec (70.09 bpm)

SENSITIVITY:

'+ 1.50 mV - 1.50 mV Since the preliminary testing determined it was functioning normally, our laboratory performed environmental thermal stress testing on this unit.

We

' feel this test is an effective in vitro method of inducing a potentially defective component to exhibit its failure mode.

This involved testing the output parameters after the unit had been reduced to a temperature of 32*F and elevated to a temperature o f_ 125'F.

In. each of these tests, the unit functioned within specifications.

A segment, consisting of the proximal 18.5 cm of the lead, was tested for electrical and material integrity.

This evaluation produced the following results:

Dried blood was present in the distal coil. The electrical continuity of the segment was complete.

The returned portion was found to be functionally normal.

While no analysis is possible on the distal portion of the lead, the condition of the segment left implanted may have contributed to the noncapture situation that you reported.

Dr. Branco, on behalf of Medtronic, I would like to thank you for selecting the Spectrax SXT" Model 8422 and Tenax 9 Model 6962 as your replacement pacing system. The continued confidence that you show in our cardiovascular products is valued highly,

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Marcelo Branco, M.D.

-December 3. 1986 Page.Two'.;

We are. committed to.providing you with the highest quality pacing-products-and

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services available.-..If we may be.of' any. further -assistance.to, you, please -

contact me directly.or through your Medtronic.. Representative, Denny :Zeidler, at 502/583-0536.

Sincerely, MEDTRONIC,--INC.

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John M. Otto Consumer Affairs' Coordinator 800-328-2518 (x4452)

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Denny Zeidler 20-04-47 John Hanley' 20-04-00 J019-2 ny 4

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PACEMAKER PROCEDURE REPORT SEPTEMBER 15, 1986 BRIEF CLINICAL HISTORY:

Mr. Preston is a 65 year old white male who is status post ASD repair in~ 1968.

He subsequently had a pacemaker placed in 1968 for apparent third degree heart block.

Since that time he has had his pacemaker replaced four times with the last repair occurring in 1978.

On 9/1/86 the patient had an episode of mid-abdominal discomfort and.noted that his heart rate was in the 60's and called in to have his pacemaker check and was referred to his nearest VA.

He was seen at the Cincinnati VAMC and was recommended to be admitted but he refused and came to Lexington. He was found to be in atrial flutter with a IVCD and subsequent rhythm strips showed him to have failure to sense properly.

A right heart catheterization was also performed which showed him to have a RA pressure 7, RV pressure 40/7, a PA mean pressure of 20 and a pulmonary capillary wedge pressure of 8; his shunt

'i-calculated to be'1.2 - 1.

g PROCEDURE:

Af ter obtaining informed co7s'ent, the patient was premedicated with Diazepam 10 mg po.and taken to the catheterization lab.

The' right intraclavicular area (where his pacemaker was located) was draped and prepped in the usual fashion and after obtaining local anesthetic with 1% Lidocaine a transverse incision was performed at the site of his previous incision.

Blunt dissection was then carried out using Metzenbaum scissors and the p:evious pacemaker generator was removed.

The lead was then checked and found to have an abnormally-high resistance and an 18 guage spinal needle was then used to i

cannulate the right subclavian vein. A guidewire was then inserted into the vein and the vein was then dilated with a 7 French fc11 owed by a 10.5 i'rench sheath and dilator. The guidewire and dilator were removed and the sheath remained in the venous system. A Medtronic pacemaker lead was then inserted through the sheath and positioned under fluoroscopy in the right ventricular apex and the peel-away sheath was then recoved and a figure of eight hemostatic suture was then placed around the lead 'and its insertion in the pectoralis muscle with a O silk suture.

The sensing and pacing thresholds were then checked and found to be acceptble and the hemostatic suture was then secured. O silk sutures were then utilized to secure the plastic sleeve to the lead and the lead was then ;ttached to the prepectoralis fascia.

A lead tug test was performed and was found to be adequate.

The ventricular lead was secured to the generator which was then sewn into the prior subcutaneous pocket an,d the old lead was capped and tucked into the pocket also.

The wound edges were then apposed with two layers of 4-0 dexon in a running suture and

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TYPE OF REPORT (Check orF slGNATURE oF PHYstCLAN/ DENTIST Q History ANo PHYS! CAL g D!sCHARGE

SUMMARY

EXAM (SF J04,505, 306 or (VAF 10 2000, a ar.d t)

FATIENT s NAVE PAF forsrs e,6, d ar.d <>

PRESTON, Gilbert SottAL SECURITY NUMBER DATE oF BIRTH g PROGRESS NOTE (SF 307) Q AUTOPSY PAoTocol 98815 tsrsos)

VA g co s TAT 1oN SHEET g OTHER (Specyg) y WARD /1EHutt DAll D;c1 ATED DATETulD Q oFEMTioN REroRT 15T510

the subcuticular edges were apposed with 4-0 vicryl.

The skin was then cleansed and the wound edges were covered with Betadine and steri-strips.

The patient tolerated.the procedure with no apparent complications and was returned to his room in good condition.

A follow up chest x-ray showed no evidence of hemothorax.

PACEMAKER DATA:

The generator is a Medtronic pacemaker riiodel f 8422, serial #

HJ2027285H.

The' parameters at implantation are:

mode VVI, sensitivity 2.5 mvolts, rate 70, hysteresis none, pulse width 0.5 msec, refractory pried 325 msec, output 5 volts.

Lead parameters:

The lead is model # 6962-58, serial #

UB0076310Y.

The parameteers at implant are:

voltage threshold 0.4 volts, with 0.5 MS pulse duration, current threshold 0.6 MA, lead resistance 567 ohms, R wave amplitude greater tbn 25 mvolts.

The removed pacemaker was a Medtronics 9000 and parameters at removal included lower rate 69, ventricular output 5.4 volts, ventricular pulse width 1.34 msec, ventricular sensitivity 4.0 mvolts, ventricular refractory period 200 msec, lower rate 865 msec, ventricular current 10.8 MA.

The old lead parameters included a bipolar resistance of 4500 ohms, a unipolar distal resistance of 4200 ohms and a unipolar proximal resistance of 274 ohms.' The R wave amplitude was 16.4 mvolts, output 8.1 mvolts, ventricular current 1.8 rrA.

)%LM l MALCOLM A. KING, M.D.

MARCELOBkNCO,M.D.

Cardiology Fellow Instructor in Medicine sbs TYPE OF REPORT (Chrek ord) slGNATURE OF PHYstCtAN/ DENTIST

] history ANo PHYstCAL

[ DISCHARGE SuMVARY EKAM (SF sos, sos, sos or (var 10 2000, a and t)

PATsENT S NAME PAF 10 tm c. 6, d and c)

PRESTON, Gilbert SoclAL SECURITY PGMBER DATE OF BIRlH g PROGREs$ NOTE (SF 502) D AUTOPSY PROTOCOL I'd 1 b (SF 303)

^?xington,KY O cASgTATioN SHEET O '* " (SP'd!d t

f W ARD/S E hv.0 L DA1E DiCI ATER DAIETYPED O oFERAfloN REPORT isrsw YA F RM 10 Ci n'4 d M EDICa l R ECO R D R ERO RT

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e Medice! Cen;er 3200 Vine Street Cincinnati OH 45220 -

M Veterans

%G# Administration April 24, 1987 in Reply Refer To: 539/115 Program Assistant, Nuclear Medicine Service (115)

Room 963 V.A. Central Office Washington, D.C.

20420-

SUBJECT:

License' renewal (SNM-1735) for Nuclear Powered Pacemakers Enclosed is the information needed for renewal of the Nuclear Powered Pacemaker License.

P Donald L. Ziegenhorn Medical Center Director i

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a MedtroniC :3 Pl. jDUCT EVALUATION REPORT instruc tons use trus te ns to renceri your espeneoce mth a VectroNc product or whe onal sis lhes enformat.on es necessa y and w N espey tc piecesseng for ma y

hease endote ruNie I and niiat twentets of ite de rtds) an.o sed r

~ Lead (s)Medcl No ;

Pybe Centratos MoJef toa -

Serial No :

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gnoO CKoO*217 Mudcl No :

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• GENER AL INFORMATION Piip t.an hi,

MAM 0 Hospital F'g:,ent Name.

VA.

Street Address title of 6mpiant

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CLINIC AL INF ORV.ATION

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NOTE: Piesee include att pertinent es *decalreeords including EKG's.

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Ceported Esperience:

O Electrve Replacement

. O sattery o,pieiion V ncanto,e O Pat.ent Espired I

O pas,iion,ng o,ft,eutry No Rate Change O o,ersens,n, O

O int,ct,on N,

D $gn vn,,snoid epm io opm O uneersensinD O tiosion O

'$S' ','d w i

No outpui O progra m m;ng o,ii,cu>i, O oiw,rpiease,,,m n3:

O v,sust erreguiar,ir. --

O striet o.ri.eutte l

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M.Wu.

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Reporte.! e a pe rienc e. r' d

O Cor fin'vously Pacing Made

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, e.cs obst r.ed M tr te ven4ttently m Me..mpia nt ed O DDD O VVi O oV, O 5e.-

.3 Program +ed Farameters wtnte implanted.

'Pulserns;mtu;e a.-

_ f.o isp Pv4e Weath.

, 5e rut.vg

_ Pulst Interval. Rate),

Pe'ractory A.V Inte rval, s

O R,sse d O neo..,ed O unico ar, red O

R,r os,t.e ne d de p.,eed D capped REPL A CEME NT INFORM ATION r? se pt;r ini 6:t irp.te ma r! c.4et$ t i Pulse Ger.eratos lY ? 0 ? 7?";&i' ; tad (s) VC h'fio

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