ML20212F820

Application for Amend,Terminating License SNM-1751.Nuclear Pacemaker Removed from Patient on 840113 & Returned to Medtronic,Inc

ML20212F820
Person / Time
Site:	07002651
Issue date:	04/30/1986
From:	Prelesnik W MANCHESTER MEMORIAL HOSP., MANCHESTER, CT
To:	Lester Tripp NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I)
Shared Package
ML20212F781	List: ML20212F777 ML20212F800 ML20212F809 ML20212F820
References
105466, NUDOCS 8608130398
Download: ML20212F820 (7)

Text

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\\t.insheter. C.mnectwut tiNLM4188 Warren L. I'relesnik. F.\\f II A Telephone 20.t+461222 rresident a ci o April 30, 1986 U.S. Nuclear Regulatory Commission Region I 631 Park Avenue King of Prussia, PA 19406-1498 Attention:

Mr. Lester Tripp This letter is to inform you that the Nuclear Pacemaker has been removed from our patient and sent back to Medtronic Inc. of Minneapolis, Minnesota.

It was removed-on-January-13, 1984.

We request that License #SNM-1751, Docket # 070-02651 be terminated.

Sincerely, f

Warren L. Prelesnik President WLP/jt Mr.Kuzmickas!

cc:

- Dr. Heimann, Chief of Nuclear Medicine Dr. Sinatra, Chief of Cardiology

.Mr. Borek 8608130398 860606 REG 1 LIC70 SNM-1751 PDR Dedicated to the Memory of Veterans of all Wars

CONSULTATION SHEET l

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504-222

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V. ABRAHAM KURIEN o.te January 13, 1984 Meier ce toe eteve mentioned petsent concermng-CARDIAC CONSULTATION WICKERSHAM Requested by:

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CONSULTAr.!ON REPORT Findings:

Date: January 13. 1984 HISTORY:

This 38 year old man was admitted to the hospital because of a malfunctioning pacemaker system.

I have been asked to review the patients pacemaker function to determine appropriate procedures for correction of pacemaker malfunction.

This patient developed complete heart block in 1977 and had a nuclear pacemaker put in.

Since that time it was not very clear whether he had ventricular septal defect which he claimed he had a youngster.

It was decided to put in an apicardial pacemaker.

This functioned adequately till 1981 when there was pacing failure due to fracture of the epicardial wire system.

Since it was by that time established that the patient had known ventricular septal defect it was decided to put in a transvenous pacemaker wire and connect him up to his original nuclear pacemaker.

This was done and his pacing function had been good till 12-14-83 when it was last checked by Cardiocare, they found that monitoring was transtalephoni-c"Ch.

Cardiocare system monitored him yesterday and called Dr. Tehrani, the thoracic surgeon to inform him that pacemaker function was inappropriate and that Recommendations:

there was pacing failure intermittently.

I Contacted-Cardiocare and found that the pacemaker output was occurring at the frequency of 69/ minute but there were periods of pacing failure when the patients heart rhythm was only 38/ minute and in view of this I arranged for him to be admitted to the hospital.

Review of rhythm strips and 12 lead EKG taken since admission shows that the patients atrial rate is 100/ minute and he has complete heart block with ventricular response of 36-38/ minute but with pacemaker function intermittently present with pacing rate of 69/ minute.

The patient was not in cardiac failure or having any other cardiological symptoms.

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patient admitted to having some di::iness recently but had thought that this was related to his recent upper respiratory infection.

Clinically, the patients blood pressure is satisfactory at 140/76, pulse is somewhere between 55-60/ minute with intermittent pacing failure 1

secondary to His intrinsic heartbeat shows left bundle branchblock]3decuatesensing.

pattern.

Dr. Tehrani and I have reviewed the chest x-ray, there is no change in the electrode position within the heart.

There possibly is an area of continuation of the pacemaker wire in the region close to the pace:naker with significant twisting of the pacemaker wire close to it.

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It seems possible that the pacemaker malfunction is related to inappropriate transmission along the pacemaker wire, especially the sensing function seems more impaired than the pacing function.

1 I feel that the patient's pacemaker should be explored to test both the pacemaker and the pacemaker wiring independently to see where the malfunction is cnd appropriate corrective action-taken.

l I

Thank you very much for asking me to see this patient.

If you should require further help in his management, please do not hesitate to get back in touch with me. -

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'&dLM V. ABRAHAM KURIEN Z D./srl D1-12-84 T1-13 cc/Dr. Kurien -1 cc/Dr. Wickersham -1 cc/Dr. Tehrani -1 q

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9 REPORT OF OPERATION 504-222 p,

1/13/84 Surseen: Dr.

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AM AM Amesthetist:

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Preoperative Diasnosis Ma1functionine oacemaker

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Postoperative Diagnosis Same op,,.sg.,

1) Removal of the previous ~malfunctionine oncemaker'from the right side

2) Implantation of ~a brand new permanent demand ~ cardiac pacemaker on the'1 eft side h

HISTORY:

This 38-year-old white male.was ad-mitted to MMH with history of symp-toms of dizzy spellsTwhich he-attrib ~ t~ed to a coldFHe~ had -

u implantation of a nuclear powered pacemaker eight years prior to this admission.

He was getting along pretty well, until he started having these symptoms.

The patient was under Cardiocare monitoring followup.

on the same day on which ho felt the dizzy spell, the Cardiocare was checked and it was found the patient has ventricular response to 38/ min. and obviously, malfunctioning pacamaker and non-capturing and non-sensing.

The patient immediately was admitted to the hospital and the problem was discussed with him.

Attempt would be made for correction of t$,is pacemaker and if no, certainly a new implantation of pacemaker to be made.

I fully explained to him about the reason, the disecafort, the complications, the potential risks well explained.

Following agreement, the following procedure was made.

PROCEDURE:

With the patient under general anes-thesia, with endotracheal tube, the entire chest and both shoulders were prepped and draped in the usual fashion.

At the level of the right deltopectoral groove, incision was made over the previous scar.

The nuclear power pacemaker generator was removed and both poles disconnected from the generator.

Tested the electrode.

It was noticed practically no capturing could be obtained as a result of the malfunction of the electrode in that regard.

I tested the electrode on the operating table, first while the electrode at the site of the connection of the electrode into the generator, was completely leaked and the plastic material was completely off and in general, the battery was almost disintegrated in that regard.

We tested the battery, showed very low output, and also, specifically, the rate was dropping.

At this time, telephone CONTINUED M. D.

CR 1 Rev. 5/77 sersson u

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A call ccdo to tho Minocring D pertm:nt of tL_-Medtronic Pcccmakot in Minnocpolis and rccommendatien wno ecdo, in that circumatenca, that this pacemaker should not be implanted, in that regard.

On the basis of that, I elected the pacemaker to completely be removed and the wire at this site was closed and the wound was irrigated with Prostaphlin solution.

Subcutaneous was closed with 3-0 Dexon and skin closed with staple suture material.

Then the attention was made toward the lef t side.

Due to the fact that the patient had heart block, symptomatic, elected the patient to have a brand new pacemaker.

At the level of the left deltopectoral groove, inoision was made, cephalic vein was identified, and bipolar lead Medtronic pacemaker inserted into the cephalic vein, under direct fluoroscopy, into the right ventricler Adequate capturing was done satisfactorily to about 0.7 ma.

Sensing threshold was adequate, satisfactory.

Electrode secured at the site of the veno-tomy very well.

Through the same incision, a pocket was made and both poles were connected to the lithium iodine Medtronic Spectrax pacemaker and adequate capturing was done.

Generator secured at i

the level of the pectoralis subcutaneously and satisfactorily.

The wound was irrigated.

Subcutaneous was closed with 3-0 Dexon, skin closed with staple suture material.

While his condition was satisfactory, he was transferred to recovery room in good and satisfactory condition.

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HOSSEIN

. TERRANI, M.D /ngb D1 84 T2/11/84 cc: Dr. Tehrani (1) v m

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WC-6f"62 'T6sTop h -OS)1 7I Haynes Street Manchester, Connecticut gyg Warren L. Prclesnik F. A.C.H. A.

Telephone 20M46-1222 President & CEO April 30, 1986 U.S. Nuclear Regulatory Commission Region I 631 Park Avenue King of Prussia, PA 19406-1498 Attention:

Mr. Lester Tripp This letter is to inform you that the Nuclear Pacemaker has been removed from our patient and sent back to Medtronic Inc. of Minneapolis, Minnesota.

It was removed on January 13, 1984.

We request that License #SNM-1751, Docket # 070-02651 be terminated.

Sincerely, Warren L. Prelesnik President WLP/jt P

cc:

Mr. Kuzmickas

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Dr. Heimann, Chief of Nuclear Medicine g

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C Dr. Sinatra, Chief of Cardiology 35 A

Mr. Borek

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Jedicated to the Memory of Veterans of all Wars MAY 0 61986

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APPLICATION ATTACHED Applicant /ticensee: borb4cir (bmcrinl \\%fgidul Application Dated:

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Control No.:

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LICENSE FEE MANAGEMENT BRANCH 1.

Fee Category and Amount:

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Correct Fee Paid.

Application sey be processed for:

Ar.endment V

Renewal Licer.se Signed h4,m,'c, D, w Date di VJ6 Q RM 213

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