ML20212F421
| ML20212F421 | |
| Person / Time | |
|---|---|
| Site: | 07002974 |
| Issue date: | 09/08/1999 |
| From: | Rada H NORTH KANSAS CITY MEMORIAL HOSP., NORTH KANSAS CITY |
| To: | Madera J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION III) |
| References | |
| NUDOCS 9909280173 | |
| Download: ML20212F421 (5) | |
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I kspital m;g.m September 8,1999 John Madera Chief Nuclear Materials Safety Branch ~
l U.S. Nuclear Regulatory Commission, Region III 801 Warrenville Road s
Lisle, Illinois 60532-435i Re: License N. SNM-1910
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Dear Sir:
This letter is in support of the letter sent to you August 12,1999 by Chris Angel, CNMT, pertaining to the recovery of the Cordis Nuclear Omni-Stanicor Model 184A nuclear powered pacemaker generator, serial # 184A-00614, that was implanted on Brian H. Lawrence on July 31,1979.
The generator described above was shipped to:
Return Device Lab Accufix Researh 75 ' West Commerce Center, Unit 23 Hialeah, Florida.53016 Enclosed are supporting documents required for this procedure.
IfI could be of further assistance, please don't hesitate to call me at:
Tel. No. 816-691-1861, Fax no. 816-691-1872.
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.Rada RECEIVED Mdnager Radiology SEP 131999
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- REMOVAL AND RECOVERY DATA TO BE COLLECTED DURING CLINICAlt
mm gg,u f EVALUATION OF A NUCLEAR-POWERED IMPLANTED CARDIAC PACEMAKERM -
Retum this form to Accufix Research Institute, 7307 S. Revere Pkwy, Englewood, Co. 80112 wrthin 10 days after removal and recovery of the pacemaker.
DATA ON FILE:
Model/ Serial # 1 g tJ A le l4 Patient Name: 9.,c ich 4, I (WrmC.e implanting Hospital: %ch Kenw (S %,14g hj Date implanted:
'7 - 3 1-K79 PATIENT INFORMATION:
Patient Name:
Bricih 6 IRwJrM LE Social Secunty #: 01 e, D - t@ 3 l Date of Birth: 4. L - 19 4 i Address: p, A M )$o 6
%ynq,(MO f,yogp R:sponsible next of kin: (name, relationship, address, telephone #)
De_ntse htMRAC C-M g g g p4i e a u so v
w PHYSICIAN INFORMATION:
br-l [ but(
Otham b.beI Attending Physician
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-r Referring Physician hd_ Kr5 6 jd MCD 0h tAcwds Dr. SdM WO Address:
Mer% lb[s45 Cdy lethatd.Sta W e+ lay O 10 $[
gaa S Address:
Atb le4Ilb f. M6 Explanting Cardiologist: tdOsu, Explanting Surgeon: Krwt R. Nrb Date:
Hospital: No d Raasas (W I4os o, i b i LEAD AND GENERATOR INFORMATION:,,rch %%5 i
Lead Type: bvh
- P1 cs udl-kaod (_b b' pac Position: No1m M @ No2 LA. N pc/ C h.2 S k U R.((
Threshold
- ma f.3 volt R msec lM Site of Insertion:
R-wave measurement method Nuclear Powered Generator Type and Model: fu m p3 IBM tr.tr;otd Serial # 194 Pt to ty Rate at time of explant:
Fixed rate Magnet Rate:
a r,. i r J
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g MEDICAL INFORMATION:
lg 4 gg gg g jg R:ason for removal:
Patient's condition at the time of removal of the pacemaker: gg U g'$g h
if deceased, cause of death:
In the opinion of a medical professional, did the device cause or contribute to the death of the patient?
yrs __ no _
Condition of.tgevige atgtgegrecovery: dL bhlos cud hsw y OdkCtktcdbons $urYoundi g
Status of leads at the time of removal: }diqi d C ha d s.4 0
- Thresholds should be measured with a battery powered extemal pacemaker having an adjustable current amplitude calibrated to an accuracy of i
s 110% and a pulse duration of 15% of the utse duratiop of the implanted pacemaker.
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Physician's signature:
Date:
l Distributtort White Directorate of Licensing, USAEC; Canary - Accufix Research Institute; Pink - Hospital; Goldenrod - Physician FPP1008.0
o o
NORTH' KANSAS CITY HOSPITAL 2800 CLAY EDWARDS DR.
NORTH KANSAS CITY, MO 64116 NUCLEAR' MEDICINE DEPARTMENT RADIOACTIVE SHIPPING REPORT 8-gInstrument dato:
99 tech: c angel serial #
cal. date battery cal. ck effic.
survey ludlum 14c 89379 02-08-99 ok ok wipa picker /ludlum 225090/2819 10-19-99 ok 89%
Label Tran Radiation mR/hr wipe test-results type index cpm dpm white I bkg:.04 mR/hr bkg: 1282 1M
.04 mR/hr outer: 1362 90 surf:.25 mR/hr inner: 1744 519 Total activity: < 3 Ci Plutonium 238 (02 solid) oA m f
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1 o
o DATE:
M-(CORRESPONDENCE CLARIFICATION SHEET)
REVIEWER:
JOHN MADERA i
LICENSEE:
LICENSE NUMBER:
M'~ M/0 The following correspondence has been received from the above licensee and it is not clear what action (s) is(are) required: Please review this correspondence and indicate which of the following applies, and please return to Debbie Hersey, as scan as possible.
l O Additional Information to Control No.
. Process in as a new action, additional information, and no fee required.
O Process as new licensing action. Review has already been started on Control No.
and this information cannot be combined with current in-house action.
o Can be combined with Control No.
. Review has not started.
Appears to be information for the license file - file it.
O Licensee is adding Nuclear Pharmacists.
Amendment is necessary Amendment is not necessary (Information for license file)
O Licensee is adding authorized users.
Amendment is necessary Amendment is not necessary (This is a Notification) o Process in as a new licensing action:
A. Amendment B. Renewal C. New License Application Other:
X A
W
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Than ou or Your Helpill 03/27/99 J