ML20211K774
| ML20211K774 | |
| Person / Time | |
|---|---|
| Site: | 07002213 |
| Issue date: | 02/06/1976 |
| From: | Castle L, Sheldon W CLEVELAND CLINIC FOUNDATION, CLEVELAND, OH |
| To: | NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20211K381 | List: |
| References | |
| 0325, 325, NUDOCS 8702260664 | |
| Download: ML20211K774 (2) | |
Text
r e
76 -2 u3 9-p,s 1..
e_ g wa
- e*h>q ]W o
b k.'d f%
,g t
CLEVELAND CLINIC y.....,.q......,Tc THE CLINIC CENTER
- 9500 EUCLID AVEN'JE, CLEVELAND, OHIO 44106, U.S.A.
216/229
. CABkff\\
LNLV.,Il v.
February 6, F
Cc.~ *'
Chief, Materials Branch
~u 'A00 C,
U.Se Nuclear Regulatory CTmission e
7 Division of Materials and Fuel Cycle Facility Licensing Washington, D. C.
20555 Re: Application for license to participate in the research study involving the implantation of Nuclear Omi-Stanicor #184A,,,
nuclear powered pacemakerse Gentlemen:
'Ihe following information is subnitted in application for a license to participate in the investigational program utilizing Nuclear Onni-Stanicor #184A nuclear-powered pacemakers:
M b//s 1.
Applicant:
/NP v>
Cleveland Clinic j
,p s
9500 Euclid Avenue
/ _!
2 - '.g -
'i
. I Cleveland, Ohio 44106 46J
. aj
~.
',7 4
2e Physician responsible for study:
/ ~f Ion W. Castle, M. D.
N Y,. '.q[,
a Cleveland Clinic s.
9500 Euclid Avenue
\\c Cleveland, Ohio 44106 229-220 Extension 1337 States licensed to practice in: Ohio and Pennsylvania l
Specialty Board Certification: Internal Medicine & Cardiology Previous experience in clinical inplantation and follow-up of l
pacemakers by physicians have been inplanting cardiac pacenakers for five years at the Cleveland Clinic. Have implanted close to 500 pacemakers to date. Have an annual follow-up of about 1,600 checks per year by telephone or in Pacemaker Clinic.
3.
'Ihe protocol to be followed is the master protocol for clinical evaluation of the program were Cordis Nuclear Omni-Stanicor pacemaker dated October h
1974.
8702260664 861021 r)h REG 3 LIC70 p
DEPARTMENT OF C ARDIOLOGY Woe.an* C. Shelden. M D Head Sect.on of tese Caed.ac Laboestory Section of E secteoceediography Section of the Caed.ac F unction L aboratory E set K Sheaey. M D, Head Hector Lardane. M D Royston C. Lewis, M D, Head Wayne S.eget M D. Head Khoteoise Doeotte, M D.
Daneet F. PNHept. M D Nest J Hatt. M O Lon W Cast $e. M D erving F rance, M O Mend + Masava. M D James R Hoagmaet. M D Y. Jusee L.m. M D Fred A Haupter Jr.. M D.
Gustavo Hencon. M O W.H.am L Peoud' t. M D E enesto E. Sa cedo. M D e
John R Keamor, M O F. Mason Sones, Jr.. M D
1 r
(-
(~
p, (a
F Chicf, Materials Branch February 6, 1976 Re: Application for license Page 2 4.
Approxirately three Nuclear Omni-Stanicor #184A pacmaker to be implanted in a year.
The pacmakers are inplanted in the Cardiac Catheterization Lab usually under a local anesthetic. An image intensifier is utilized for fluoroscopy purposes. Stinulating and sensing thresholds are measured by the Medtronic 5300 pacemaker systes analyzer. Uhresh-olds are checked by voltage and milliarperage with olmes resistance calmlated and millivolts sensing signals are recorded. We are inplanting about 150 pammkers per year and have about 600 patients in our pacemaker follow-up system. 98% of our pacemakers are inplanted by endocardial method with about 2% using riyocardial leads. About 98%
of our patients are done under local anesthetic.
Our records are maintained both in the patients chart and in a separate pacemaker file where all patients are listed individually. Because of the size of our follow-up system we are now at the present time beginning to cmputerize our pacmeker clinic.
Adequate security exists at the Cleveland Clinic to have appropriate control procedures to insure the physical security of the pacemakers.
The units will be kept track of by their serial nunbers anc. locations.
They will be under lock and key when not in use. These sh:mld confirm to regulations under Title X, Code of Federal Regulations Part 70.
Follow-up for pacmaker probles ccme to the Cleveland Clinic through the pacemaker watts line. This is open for information 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> a day seven days a week. This ntnber is area code 216-229-8751. We are familiar with the master protocol and will follow this for implantation and follow-up. Follow-up information will be given to proper sources.
Packaging, laboring, and shipping instructions will be followed as instructed fr m the Cordis Corporation.
We hereby request the license to receive, possess, store, and inplant the Nuclear Quni-Stanicor #184 nuclear powered pacmaker in accordance with this inplantation.
Cleveland Clinic tJ Ion Castle, M. D.
William C. Sheldon, M. D.
Head, Department of Cardiology Reviewed by Mr. Edward S. Chernak, Radiatio' Safety Officer for Cleveland Clinic cc: Cbrdis Corp.
P. O.
Box 307428 Miami, Florida 33137
.