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 NRC/IE
To:
References
IN-86-059, NUDOCS 8607090442
Download: ML031250038 (3)

SSINS No.: 6835 IN 86-59 uIlTED STATES.NUCLEAR REGULATORY

COMMISSION

OFFICE OF INSPECTION

AID ENFORCEMENT

WASHINGTON, D.C. 20555 July 14, 1986 IE INFOWATION

NOTICE NO. 86-59: INCREASED

MONITORING

OF CERTAIN PATIENTS wITH IMPLANTED

CORATOMUC.

INC. MODEL C-100 AND 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 possible problems with certain units. The manufacturer

recends increased

monitoring

of patients with these units iplanted.

It is ewpected that licensees

will review this information

for applicability

to their patients and consider actions, if appropriate.

However, suggestions

contained

in this information

notice do not constitute

NRC requiretments;

therefore, no specific action or written response is required.Description

of Circunstances:

By letter dated March 14, 1986, the manufacturer, Coratomic, Inc., notified applicable

attending

physicia.s

of possible problems with Model C-100 and C-101 plutoniuawpowered

pacemakers

that were manufactured

between September

1974 and October 1977. During that time, '2CM potting material,'

a glue-like

substance, was used In the construction

of the pacers. The reversion

of the 2CN potting material to a viscous form in some units has lead to a rate drop nd to a higher-than-anticipated

random transformer

failure rate. Accordingly, Coratomic recoemends

that the monitoring

of affected patients be increased

to once every 3 months. The March 14 letter included a listing of affected patients.Discussion:

There Is no radiological

hazard associated

with the problem described

in Coratomic's

March 14, 1986 letter. However, this notice serves as a reminder that, as a condition

of their license, licensees

are required to follow the manufacturer's

protocol and to notify the NRC within 10 days of loss of contact with a nuclear pacemaker

patient. If you have any difficulty

locating or contacting

any affected patient, the NRC suggests you contact the manufacturer

for assistance.

However, since the Coratomic

protocol, dated either August 1.1974 or November 1, 1975, specifies

in-person

followup visits every 6 months for patients with Coratomic

Model C-100 or C-101 pacemakers

implanted

for more than 6 months, you should have no difficulty

in contacting

affected patients.OV" 7 re _ ~

II IN 86-59 July 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 Regional Ainistrator

of the appropriate

NRC regional office or this office.Jas G. Partlow, Director ODvision of Inspection

Progrems Office of Inspection

and Enforcement

Technical

Contact: J. R. Netzger, IE (301) 492-4947 Attactnt:

List of Recently Issued IE Information

Notices

Attachment

1 IN 86-59 July 14, 1986 LIST OF RECENTLY ISSUED IE INFORMATION

NOTICES Information

Date of Notice No. Subject Issue Issued to 86-58 86-57 36-56 86-55 86-54 Dropped Fuel Assembly Operating

Problems With Solenoid Operated Valves At Nuclear Power Plants Reliability

Of Main Steam Safety Valves Delayed Access To Safetr Related Areas And Equipment During Plant Emergencies

Criminal Prosecution

Of A Former Radiation

Safety Officer Who Willfully Directed An Unqualified

Individual

To Perform Radiography

Improper Use Of Heat Shrink-able Tubing 7/1V86 7/11/86 7/10/86 7/10/86 6/27/86 6/26/86 All power reactor facilities

holding an OL or CP All power reactor facilities

holding an OL or CP All PMR holding facilities

an 0L or CP 86-53 86-52 Conductor

Insulation

Degrada- 6/26/86 tion On Foxboro Model E Controllers

Excessive

Pneumatic

Leakage 6/18/86 In The Automatic

Depressuriza- tion System All power reactor facilities

holding an OL or CP All holders of by-product, source, or special nuclear material All power reactor facilities

holding an OL or CP All power reactor facilities

holding an OL or CP All BWR facilities

holding an OL or CP All power reactor facilities

holding an OL or CP All power reactor facilities

holding an OL or CP 86-51 86-50 Inadequate

Testing To Detect Failures Of Safety-Related

Pneumatic

Components

Or Systems Age/Environment

Induced Electrical

Cable Failues 6/18i86 6/16/86 86-49 0L = Operating

License CP = Construction

Permit