ML20235G362
| ML20235G362 | |
| Person / Time | |
|---|---|
| Site: | 07002707 |
| Issue date: | 08/22/1977 |
| From: | Chi S, Gonzalezlavin, Mcree E INGHAM MEDICAL CENTER, LANSING, MI |
| To: | Singer B NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20235G320 | List: |
| References | |
| 07676, 7676, NUDOCS 8902230223 | |
| Download: ML20235G362 (4) | |
Text
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-e 11 401 WEST GREENLAWN, LANSING, MICHIGAN 48909 (517) 374-2121
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C August 22,1977
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Office of Nuclear Material Safety and Safegu[ards g O
- ***s U.S. Nuclear Regulatory Commission Washington, D.C. 20555 y
m ATTENTION: Mr. Bernard Singer RE: Application for license to implant Medtronic' Model 9000 Isotopic Pulse Generator Gentlemen:
The following information is submitted in application for a license to implant the Medtronic Model 9000.
l.
Applicant: Ingham Medical Center
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2.
Physician responsible for study:
Name: Lorenzo Gonzalez-Lovin, M.D.
Office Address: 405 West Greentown, Suite 220, Lansing, MI 48910 Telephone Number: 517/374-2306 State Licensed to Practice in: Michigan 31439; California A30915 Specialty and Board Certification: Am Board Thoracic Surgery Cardiothoracic Surgery Position with Hospital: Cardiac Surgeon Dr. Gonzalez-Lovin implants 5 to 10 pacemakers per year and has 10 years pacing experience.
Physicians and surgeons participating:
Name: George E. Kleiber, D.O.
Office Address: Cardiac Clinic,405 W. Greenlawn, Suite 220 Lansing, MI 48909 Telephone Number: 517/374-2304 State Licensed to Practice in: Michigan #5979 Specialty and Board Certification: Cardiology: American Board of Osteo. Internal Medicine Position with Hospital: Cardiologist Dr. Kleiber follows approximately 12 pacemaker patients.
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Name: Seong H. Chi, M.D.
Office Address: 405 West G/eenlawn, Suite 400, Lansing, MI 48909 Telephone Number: 517/372-6327 State Licensed to Practice in: Michigan Specialty and Board Certification: American Board of Surgery Part i 1974 Position with Hospital: Private practice-cardiovascular and thoracic surgeon Dr. Chi implants 25 to 35 pacemakers per year and has more than 10 years experience in pacing.
Name: Walter M. Baird, M.D.
Office Address: 405 West Greenlawn, Suite 220, Lansing, MI 48909 Telephone Number: 517/374-2304 State Licensed to Practice in: Michigan Specialty and Board Certification: American Board of internal Medicine,1965 Position with Hospital: Private practice: Cardiology Director of Heart Station Dr. Baird follows 74 pacemaker patients and has about 17 years experience in pacing.
3.
Protocol to be followed: Medtronic Model 9000 Isotopic Pulse Generator protocol dated March I,1973, revised October I,1975.
4..
Number of Medtronic Model 9000 units requested to be implanted annually during study: Four 5.
Description of physical facilities and equipment:
Ingham Medical Center is a 259 bed facility with a CCU of eight beds.
We have a Medtronic Model 5300 Pacing Systems Analyzer to take the threshold measurements required by the study. We also have a nuclear medicine license.
6.
Description of applicant's present pacemaker implantation and follow-up program:
About 55 pacemakers are implanted at the center each year. The center has had pacemaker surgeries for over 10 years. Patients are followed at the pacemaker clinic located in the hospital.
7.
Description of methods used to maintain separate records:
The records of the nuclear pacemaker patients will be kept separate from the records of the rest of the hospital and the rest of the pacemaker patients. They will be kept in specific folders with dates of return visits so that we can recognize when the patient has another follow-up appointment, and we will be able to tell if he does not show up for the appointment. We are also reminded of the patient's follow-up schedule by Medtronic's follow-up data forms which are sent on a regular basis.
The folders and the separate files will also contain information on the patient's location and phone number where the patient can be reached if he does not show up for a follow-up exam.
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8.
Written Instruction'for Telephone Operators:
See attachment.
We represent that 'we are familiar with the.Medtronic Protocol and Technical Manual for the Medtronic Model 9000 and understand that the issuance of l
o license is conditioned upon use of this protocol and the use of instructions
' in the technical manual on " transporting, handling and sterilization of the.
pulse generator." We agree to have the patient visit our office for the required follow-up examinations.
We will establish appropriate control procedures to ensure that the pulse generators are not lost or stolen. These procedures will include keeping track by serial number of the locations of each pulse generator and requiring that they be kept under lock when not being used. We represent that we have adequate fire protection in case of emergency, and we will conduct all activi-ties in accordance with the NRC's regulations published in 10 CFR 70.
We agree to continue the follow-up reporting and recovery procedures required under Medtronic's protocol in the event the physician responsible for the study or any other physician or surgeon participat.ing in.the study is no longer associated with this hospital.
Ingham Medical Center hereby requests alianseto receive, possess, store and implant Medtronic Model 9000 Isotopic Pulse Generators in accordance with this application.
i Signed:
Application:
By:
Edward B. McRee, President Physicians Responsible for Study:
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sm V.GbtL Seog. Ch, M D.
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-r bdd h1 L i enzg_Go 3z-Lovin, M.D.
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' Tieorg6 Kleiber, D.O.
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A Waltef Baird, M.D.
pob Attachment 1
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e-INSTRUCTIONS TO TELEPHONE OPERATOR CONCERNING NUCLEAR PACEMAKERS 1.
Accept any collect call with reference to nuclear pacemakers.
2.
Any. call involving a patient with a nuclear pacemaker requires immediate -
action to ensure that there is no danger of radiation exposure and recovery..
l of the nuclear pacemaker.
3.
Obtain as much information from the coller as is possible including:
1 Caller's name and where he may be reached.
l Patient's name, status, and where he may be reached.
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Attending Physician (if any) and where he may be reached.
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-(Information from Patient I.D. Card)'
Patient's Social Security Number l
Date of Irnplant j
Pacemaker Serial Number i
' 4.
Notify immediately:
Name:
Seong H. Chi, M.D.
Address:
405 W. Greenlawn, Suite 400, Lansing, MI 48909 j
Phone No:
517/372-6327 l
1 If he cannot be reached, notify:
Address: '
Lorenzo Gonzalez-Lavin, M.D.
j Name:
405 West Greenlawn, Suite 220, Lansing, MI 48910 l
Phone No.
517/374-2306 If neither con be reached, contact physician on duty for the Cordiac
-j Core Unit; inform him that this involves a nuclear pacemaker; and advise him of the information you have and the urgency of the matter.
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