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

pacemakers.

All NC licensees authorized to use nuclearpowered cardiac

Purpose

and C-101 nuclear- This notice is to alert users of Coratomic, Inc. Model C-100 warning of possible

powered cardiac pacemakers of the manufacturer's recent

recends increased monitoring

problems with certain units. The manufacturer licensees will

of patients with these units iplanted. It is ewpected that

patients and consider actions, review this information for applicability to their this information notice do

if appropriate. However, suggestions contained in

or written

not constitute NRC requiretments; therefore, no specific action

response is required.

Description of Circunstances:

Inc., notified

By letter dated March 14, 1986, the manufacturer, Coratomic, C-100 and C-101 applicable attending physicia.s of possible problems with Model September 1974 and

plutoniuawpowered pacemakers that were manufactured betweenglue-like substance, October 1977. During that time, '2CM potting material,' a of the 2CN potting

was used In the construction of the pacers. The reversion

material to a viscous form in some units has lead torate. a rate drop nd to a

higher-than-anticipated random transformer failure Accordingly, Coratomic

patients be increased to once every

recoemends that the monitoring of affected

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 of loss to follow the

of contact

manufacturer's protocol and to notify the NRC within 10 days locating or

with a nuclear pacemaker patient. If you have any difficulty the manufacturer

contacting any affected patient, the NRC suggests you contact August 1.

for assistance. However, since the Coratomic protocol, dated either 6 months for

1974 or November 1, 1975, specifies in-person followup visits every

or C-101 pacemakers implanted for more

patients with Coratomic Model C-100 patients.

than 6 months, you should have no difficulty in contacting affected

7OV"

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

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 Dropped Fuel Assembly 7/1V86 All power reactor

facilities holding

an OL or CP

86-57 Operating Problems With 7/11/86 All power reactor

Solenoid Operated Valves At facilities holding

Nuclear Power Plants an OL or CP

36-56 Reliability Of Main Steam 7/10/86 All PMR facilities

Safety Valves holding an 0L or CP

86-55 Delayed Access To Safetr 7/10/86 All power reactor

Related Areas And Equipment facilities holding

During Plant Emergencies an OL or CP

86-54 Criminal Prosecution Of A 6/27/86 All holders of by- Former Radiation Safety product, source, or

Officer Who Willfully special nuclear

Directed An Unqualified material

Individual To Perform

Radiography

86-53 Improper Use Of Heat Shrink- 6/26/86 All power reactor

able Tubing facilities holding

an OL or CP

86-52 Conductor Insulation Degrada- 6/26/86 All power reactor

tion On Foxboro Model E facilities holding

Controllers an OL or CP

86-51 Excessive Pneumatic Leakage 6/18/86 All BWR facilities

In The Automatic Depressuriza- holding an OL or CP

tion System

86-50 Inadequate Testing To Detect 6/18i86 All power reactor

Failures Of Safety-Related facilities holding

Pneumatic Components Or an OL or CP

Systems

86-49 Age/Environment Induced 6/16/86 All power reactor

Electrical Cable Failues facilities holding

an OL or CP

0L = Operating License

CP = Construction Permit