ML20237G031
| ML20237G031 | |
| Person / Time | |
|---|---|
| Site: | 07001331 |
| Issue date: | 02/28/1973 |
| From: | Gage A VETERANS ADMIN. MEDICAL CENTER, BUFFALO, NY |
| To: | Malaro J US ATOMIC ENERGY COMMISSION (AEC) |
| Shared Package | |
| ML20236P571 | List: |
| References | |
| 1466, NUDOCS 8708130283 | |
| Download: ML20237G031 (9) | |
Text
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VETERANS ADMINISTRATION HOSPITAL.
3495 DAREY AVENUE BUFFALO, NEW YORK 14215 February 28, 1973 YOUR FIM
REFERENCE:
Mr. James C. Malaro Chief of Materials Branch Division of Materials Licensing Atomic Energy Commission W ashington, D.C.
20545 R e: License No. SNM-1305 Docket No. 70-1331
Dear Mr. Malaro:
We are pleased to submit to you our first formal follow -up r ep ort. As of this date, w e have operated upon nine (9) patients using the Medtronic-Laurens-Alcatel Model 9000 nuclear powered cardiac pacemaker under License No. SNM-1305 issued by your offic e.
All patients have made an uneventful recovery and we have not encountered difficulties of any kind. Informed consent w as secured from all the patients; they have been more than willing to give us permission to recover the device, in caec of death, by signing the Uniform Donor Gift Act card. The patients have been issued identification cards and bracelets according to our protocol and we have not encountered any difficulties in the follow-up and in maintenance of contact with the patients.
For the purpose of this report, we are attaching the form (Status Report) as proposed by the protocol which w as submitted to your office by the representatives of Medtronic, Inc. W e are als o attaching a narrative summary on each patient for your information, and w e have established direct or telephone contact within the past few days with eight of these patients and the next of kin of one of the patients who was unavailable at the time of our call. Several of these patients w ere referred to us from other Veterans Administration Hos-pitals and their original records had to be transferred to these institutions. However, a xerox copy of each patient's record is in our hands in a separate file and available for your inspection.
O Iffhfy 070730 SNM.1305 ppg Page 1.
Include Zip Code in your return address and give veteran's social security number.
}4 if VA number is unknown, show service number. g Show veteran's full name and VA fle number on.sil correspondence.
s O
o Page 2.
Mr. Jaraes C. Malaro February 28, 1973 My associates and Ivery much appreciate your help and assistance with this program and needless to say w e are all delighted to be able to report to you only favorable results at this tim e.
W e are also attaching a formal request to extend our license.
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Yours very sincerely, L*
Andr ew A. Gag e, M. D.
Chief, Surgical Service b
Chief of Staff Encl.
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STATUS REPORT j
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MEDTRONIC LAURENS-ALCATEL MODEL 9000 ISOTOPIC PULSE GENERATOR
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Vet erans Administration. Hospital Medical Facility 3495 Bailey Avenue, Buffalo, New York 14215 Physician Resp'onsible for Study Andr ew A. G ag e, MD.
License No.
SNM-13 05 1.
Purpose of Study.
The purpose of this study is to evaluate the operating life and reliability of this pulse generator and to evaluate the system of patient registration, follow-up, and recovery of the pulse generator.
2.
Number of Devices and Patients.
9 pulse generators have been implanted in this study in 9
patients.
4 3.
The pulse generators have been implanted for an average of months; the shortest implantation being0.3_ months and the longest implantation being 7 months. The pulse generator is presently in 9 ' patients and functioning normally. No pulse generators have been recovered.
pulse genera' tors suspected of malfunction, 4 ^.
There have been no which required replacement of the pulse generator. These have s
been returned to Medtronic, Inc. and the results of its reli-pulse ability assurance analysis received to date on generators are attached.
5.
Follow-up Data Forms are current and up-to-date on 9
patients for the patients.
Contact has been lost with no following reasons:
6.
Summary of clinical data in cases of adverse effects or mal-functions related to the pacemaker system including leads and opinion as to the nature and causes of these:
None 7.
Evaluation of the safety and reliability of the pulse generators and the procedure for its use (statement summarizing side effects, i
toxicity, device malfunction, degradation or failure):
Safe and reliable in all patients at the time of this report.
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List of Medtronic-Alcatel Radioisotope Pacemakers Implanted at the Buffalo Veterans Administration Hospital from July 18, 1972 through February 22, 1973 Name of Patient Date of 1 implantation Serial # of Unit Tasca, A. J.
July 18,1972 2R00035 Peck, R. L.
July 19,1972 2R 00037 M ark, J.
August 17, 1972 2R00009 O'Neal, Steve September 13, 1972 2R00065 W illiam s, I.
October 24, 1972 2R00043 Sawyer, J.C.
October 24, 1972 2R00096 Heater, W.
December 4,1972 2R00108 Baker, L.
December 5,1972 2R00106 Wiberg, L.
February 22, 1973 2R00131 1466
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O v3Q g g_ / 3 37 Narrative Summary
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C as e No. 1 TASC A, A. J.
48-year old male patient with known complete heart block since 1959 He w as initially operated upon in 1960 at this hospital and was the fifth patient in the world in whom an implantable pacemaker system was installed. He has been continuously pacemade since 1960 although in the past few years, because of infection, the pacemaker and part of the electrode system has been exteriorized '
and w orn by the patient as a partially external appliance.
On this admission, on July '18,1972, a radioisotope pacemaker, Medtronic Model 9000, was implanted through an upper midline abdomint.1 incision. A Medtronic Model 5814 electrode was used and affixed to the undersurface of the heart. Threshold for stimulation was determined with a constant current devic e.
The pulse width of the stimulus was 2 milliseconds, the required j
current w as 0.5 milliamperes and the voltage w as 0.2 ard 0. 4 volts at the leading and trailing edges respectively in bipolar configur ation. These initial values were appropriately low for this p a*ticular electrode. The pulse generator w as placed in the left subcutaneous area of the abdominal wall. His postoperative course was uneventful. He was seen last on February 26, 1973. His pacemaker w as functioning normally.
C as No.2 PECK, R. L.
A 45-year old male with known heart block since 1967 at which time he received an endocardiac pacing system which had to be replaced in April 1970 because of dislocation of the electrode. On April 15, 1970, a thoracotomy was performed and a Medtronic 5814 electrode w as placed on the left ventricle.
A pulse generator w as placed in a subpectoral location.
On this admission, he came in for an elective replacement of the pulse generator which was indicated at this time. A radioisotope pacemaker, Model 9000, w as used. Stimulation thresholds were determined at the time of operation, which took place on July 19, 1972, with a constant current pulse of 2 milliseconds duration. The threshold requirement w as 1.5 milliamperes with a voltage of 0.5 and 1.4 at the leading and trailing edges respectively, w ell below the capabilities of the radioisotope pulse generator with an output of 7 volts at the leading edge as measured at the time of installation. The patient's course w as uneventful. He was seen at this hospital in September 1972 at which time his pacemaker functioned normally. He will be seen again early next month but he has been contacted by telephone on February 26,1973.md is w ell.
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' C as e No. '3 '
i MARK,J.
. A 59-year 'old male who first was treated for heart block with an implanted pacemaker system in 1968. - At the time of admission to this hospital'
- in August 1972, he had an ~ endocardiac electrode. Medtronic ~ Model 5816,
- attached to a conventional Medtronic pulse generator placed in the left sub-clavicular area of the chest w all. The pulse generator required replacement at this time and a radioisotope unit, Model 9000, was used. The operation was performed on' August 17, 1972. The endocardiac ' electrode had been stable and in good position for approximately two years. Threshold s were determined at the time of operation and in the optimal bipolar configuration were as follow s:
using a 2 millisecond constant current stimulus, the threshold r.equirement was 4 milliamperes requiring I volt and 4 volts at the leading and trailing. edges respectively, well below the output voltage of the radioisotope device. His postop erative course w as e ampletely uneventful. He has been followed by his private physician, Dr. Pfeiler in Denver, Colorado. We have been in i
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. telephone contact w th the patient on February 2,1973. He is well.
C as e No. 4 O'NEAL, S.
A 59-year old male who had been treated with an implantable pacemaker system for heart block since 1968. J.t the time of admission, he had an endocardiac electrode, Medtronic Mc:lel' 5816, which had been in place and stable since 1968.
His pulse generator, a Medtronic conventional powered unit, had been in place since October 1970 and required elective replacement at this time. A r adio-isotope pulse generator, Model 9000, was installed on September 13, 1972.
Stimulation thresholds w ere determined in optimal bipolar configuration with a constant current pulse of 2 milliseconds duration. Threshold was found at 2 milliamperes requiring 0.5 and 1.4 volts at the leading and trailing edges respectively, far below the output voltage of 6.2 volts at the leading edge of the radioisotope device. His postoperative course w as uneventful. ' He has been followed at the Veterans Administration Hospital at Little Rock, Arkansas, and w as last seen there approximately two w eeks ago. We spoke to the physician, who is treating him, on February 26, 1973.. The pacengaker is functioning -
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normally. The patient is well and under7fNEE8edt foe *EI underlying cardiac dis eas e.
i C as e No. 5 Williams, I.
A 50-year old male who has been treated with an implantable pacemaker system for heart block since December 1967. At the time-of admission to this hospital, he had an endocardiac electrode, Medtronic Model 5816, and a con-ventional Medtronic pacemaker which required elective change at this time.
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Cas e No. _5 (continued)
The endocardiac electrode w as in good position and had been stable for several years. He w as operated upon on October 24, 1972 and the stimulation thresholds were determined in bipolar configuration with a voltage source emitting a stimulus of 1 millisecond duration, comparable to the output characteristics of the radioisotope pulse generator. The threshold w as found to be at 2 volts and 1 volt at the leading and trailing edges respectively,
corresponding to an output of 6.5 and 3 of the radioisotope unit attached to this particular electrode.
His postop erative course w as uneventful. He has had his most recent checkup at the Veterans Administration Hospital in New Or1 cans, Louisiana, in January 1973. His pacemaker is functioning normally.
He w as contacted directly by telephone on February 26, 1973 / He is w ell.
C ase No. 6 SAWYER, J.C.
This 47-year old male has been treated for heart block with several implantable pacemaker systems since 1961. The most recent and pertinent endocardiac electrode w as placed in the right ventricle on July 23, 1968. It is a Medtronic Model 5816 endocardiac electrode. The most recent pulse generator attached to this electrode w as a Medtronic conventional pacemaker placed subcutaneously in the upper portion of the left chest w all. The electrode has been in good and stable position since 1968. The pulse generator needed elective replacement at this time. The patient has known coronary arterial d isease which w as review ed extensively and the conclusion w as reached that no definite opinion could be rendered as to whether this would or would not be a limiting f actor in regard to a ten-year life expectancy. How ever, b ec aus e of the patient's young age and because of the f act that several surgical pro-cedures are ncw available to correct the coronary arterial disease this patient has, it was concluded that he was eligible to receive an isotopic pulse generator.
He w as operated upon on October 24, 1972. The stimulation threshold w as determined in optimal bipolar configur ation with a voltage pulse of 1 millisecond duration similar to that of the radioisotope unit. The threshold w as found to be at 2 volts at the leading edge and at 1. 5 volts at the trailing edge, w ell below the output of 6 volts at the leading edge of the radioisotope pulse generator attached to this particular electrode. His postoper ative course w as uneventful. The patient is due for a follow-up visit at the Veterans Administration Hospital in Oteen, North Carolina, in the near future. How ever, w e established direct telephone contact with the patient on February 26, 1973. He is well.
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. C as e No. 7 -
. A 49-year old male w as rc(erred to this hospital from the Veterans Administration Hospital in Cincinnati, Ohio, for implantation of a permanent implantable pacemaker system. The patient had evidence of intermittent heart block for the past six months and had a temporary pacing system in place when he arrived at this hospital. He had experienced intermittent epioodes of complete heart block and the placement of a permanent pacing system w as indic ated. A left thoracotomy w as performed on December 4,19J2 and a
' Medtronic myocardial electrode, Model 5814, was placed on the left ven-tricular myocardium.. Stimulation thresholds w ere determined with a voltage pulse of'1 millisecond duration and a pulse of 1.5 at the leading and
'I.~2 volts at the trailing edge were the threshold values. The output of the Model 9000 radioisotope pulse generator into this electrode was 6i4 volts at the Icading edge and 5.6 volts at the trailing edge with a pulse duration of I millisecond. The patient's postoperative course w as uneventful. He has been seen at the Cincinnati Veterans Administration Hospital in January 1973 and again on February 6,1973. We have been in direct contact with the cardiologist in charge of this patient. The patient is w ell and his pacemaker functions normally. We have been in direct telephone contact with the patient's sister-in-law on February 27, 1973 and she has indicated that the patient is well.
Case No. 8 B AK ER, L.
A 44-year old male w as referred to this hospital because of intermittent
- heart block. Medical workup established that he w as qualified to receive a-radioisotope pulse generator. On December 5,1972, a thoracotomy was performed and a Medtronic Model 5814 myocardial electrode was placed into the left ventricular myocardium. Stimulation thresholds were established with a 1 millisecond voltage pulse in optimal bipolar configuration. Threshold w as found to be 1. O volt and 0.9 volts at the leading and trailing edges respectively compared to a voltage output of 7 volts at the leading edge of the radioisotope pulse generator, Model 9000, attached to this particular electrode. The pulse generator was placed into the subcutaneous tissues of the chest w all in retro-pectoral position. The patient's postoper ative course w as uneventful. He was seen in January 1973 at the Veterans Administration Hospital in Temple, Texas, at which time a minor accumulation of fluid in the pacemaker pocket w as found. This did not require any treatment and subsided spontaneously.
We have been in direct telephone contact with the patient on February 26, 1973.
He is w ell.
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Case No. 9 WIBERG, L.
This 34-year old male had been treated for several years with an implantable pacemaker system. At the time of admission to this hospital, he had a hipolar endocardiac electrode, Medtronic Model 5816, in good and-stable position since its insertion in 1968. This w as attached to a conventional Medtronic pulse generator which had been placed into the subcutaneous tissues of the upper right chest w all. This pulse generator needed replacement at this time. The patient has progressive muscular dystrophy but it is not severe.
He is only mildly disabled. The disease is very slowly progressive but it does not, in our view, represent a contraindication in terms of life expectancy.
He w as operated upon on February 22,1973 and a radioisotope unit, Model 9 000, w as us ed. Thresholds were determined at the time of operation in optimal bipolar configuration with a voltage pulse of 1 millisecond duration.
Stimulation threshold w as at 2 volts and 1.6 volts at the leading and trailing edges respectively, compared to an output of 7 volts and 4 volts at the leading and trailing edges respectively of the radioisotope pulse generator attached to l
this particular electrode. The patient's course to this date has been completely uneve ntful and discharge from this hospital is anticipated within a few days.
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