Information Notice 1986-59, Increased Monitoring of Certain Patients with Implanted Coratomic, Inc. Model C-100 and C-101 Nuclear-Powered Cardiac Pacemakers

Increased Monitoring of Certain Patients with Implanted Coratomic, Inc. Model C-100 and C-101 Nuclear-Powered Cardiac Pacemakers

ML031250038
Person / Time
Site:	Beaver Valley, Millstone, Hatch, Monticello, Calvert Cliffs, Dresden, Davis Besse, Peach Bottom, Browns Ferry, Salem, Oconee, Mcguire, Nine Mile Point, Palisades, Palo Verde, Perry, Indian Point, Fermi, Kewaunee, Catawba, Harris, Wolf Creek, Saint Lucie, Point Beach, Oyster Creek, Watts Bar, Hope Creek, Grand Gulf, Cooper, Sequoyah, Byron, Pilgrim, Arkansas Nuclear, Three Mile Island, Braidwood, Susquehanna, Summer, Prairie Island, Columbia, Seabrook, Brunswick, Surry, Limerick, North Anna, Turkey Point, River Bend, Vermont Yankee, Crystal River, Haddam Neck, Ginna, Diablo Canyon, Callaway, Vogtle, Waterford, Duane Arnold, Farley, Robinson, Clinton, South Texas, San Onofre, Cook, Comanche Peak, Yankee Rowe, Maine Yankee, Quad Cities, Humboldt Bay, La Crosse, Big Rock Point, Rancho Seco, Zion, Midland, Bellefonte, Fort Calhoun, FitzPatrick, McGuire, LaSalle, 05000000, Zimmer, Fort Saint Vrain, Shoreham, Satsop, Trojan, Atlantic Nuclear Power Plant, Skagit, Marble Hill
Issue date:	07/14/1986
From:	Partlow J G NRC/IE
To:
References
IN-86-059, NUDOCS 8607090442
Download: ML031250038 (3)

SSINS No.: 6835IN 86-59uIlTED STATES.NUCLEAR REGULATORY COMMISSIONOFFICE OF INSPECTION AID ENFORCEMENTWASHINGTON, D.C. 20555July 14, 1986IE INFOWATION NOTICE NO. 86-59: INCREASED MONITORING OF CERTAIN PATIENTSwITH IMPLANTED CORATOMUC. INC. MODEL C-100AND C-101 JCLEAR-P4ORED CARDIAC PACMEERS

Addressees

All NC licensees authorized to use nuclearpowered cardiac pacemakers.

Purpose

This notice is to alert users of Coratomic, Inc. Model C-100 and C-101 nuclear-powered cardiac pacemakers of the manufacturer's recent warning of possibleproblems with certain units. The manufacturer recends increased monitoringof patients with these units iplanted. It is ewpected that licensees willreview this information for applicability to their patients and consider actions,if appropriate. However, suggestions contained in this information notice donot constitute NRC requiretments; therefore, no specific action or writtenresponse is required.Description of Circunstances:By letter dated March 14, 1986, the manufacturer, Coratomic, Inc., notifiedapplicable attending physicia.s of possible problems with Model C-100 and C-101plutoniuawpowered pacemakers that were manufactured between September 1974 andOctober 1977. During that time, '2CM potting material,' a glue-like substance,was used In the construction of the pacers. The reversion of the 2CN pottingmaterial to a viscous form in some units has lead to a rate drop nd to ahigher-than-anticipated random transformer failure rate. Accordingly, Coratomicrecoemends that the monitoring of affected patients be increased to once every3 months. The March 14 letter included a listing of affected patients.Discussion:There Is no radiological hazard associated with the problem described inCoratomic's March 14, 1986 letter. However, this notice serves as a reminderthat, as a condition of their license, licensees are required to follow themanufacturer's protocol and to notify the NRC within 10 days of loss of contactwith a nuclear pacemaker patient. If you have any difficulty locating orcontacting any affected patient, the NRC suggests you contact the manufacturerfor assistance. However, since the Coratomic protocol, dated either August 1.1974 or November 1, 1975, specifies in-person followup visits every 6 months forpatients with Coratomic Model C-100 or C-101 pacemakers implanted for morethan 6 months, you should have no difficulty in contacting affected patients.OV" 7re _ ~

IIIN 86-59July 14. LO% No swcific action or written response is required by this information notice.If you have ar questions regarding this mtter, please contact the RegionalAinistrator of the appropriate NRC regional office or this office.Jas G. Partlow, DirectorODvision of Inspection ProgremsOffice of Inspection and Enforcement

Technical Contact:

J. R. Netzger, IE(301) 492-4947Attactnt: List of Recently Issued IE Information Notices

Attachment 1IN 86-59July 14, 1986LIST OF RECENTLY ISSUEDIE INFORMATION NOTICESInformation Date ofNotice No. Subject Issue Issued to86-5886-5736-5686-5586-54Dropped Fuel AssemblyOperating Problems WithSolenoid Operated Valves AtNuclear Power PlantsReliability Of Main SteamSafety ValvesDelayed Access To SafetrRelated Areas And EquipmentDuring Plant EmergenciesCriminal Prosecution Of AFormer Radiation SafetyOfficer Who WillfullyDirected An UnqualifiedIndividual To PerformRadiographyImproper Use Of Heat Shrink-able Tubing7/1V867/11/867/10/867/10/866/27/866/26/86All power reactorfacilities holdingan OL or CPAll power reactorfacilities holdingan OL or CPAll PMRholdingfacilitiesan 0L or CP86-5386-52Conductor Insulation Degrada- 6/26/86tion On Foxboro Model EControllersExcessive Pneumatic Leakage 6/18/86In The Automatic Depressuriza-tion SystemAll power reactorfacilities holdingan OL or CPAll holders of by-product, source, orspecial nuclearmaterialAll power reactorfacilities holdingan OL or CPAll power reactorfacilities holdingan OL or CPAll BWR facilitiesholding an OL or CPAll power reactorfacilities holdingan OL or CPAll power reactorfacilities holdingan OL or CP86-5186-50Inadequate Testing To DetectFailures Of Safety-RelatedPneumatic Components OrSystemsAge/Environment InducedElectrical Cable Failues6/18i866/16/8686-490L = Operating LicenseCP = Construction Permit