CONTAK RENEWAL

MDR report key: 1953640 · Received January 10, 2011

Report

Report Number: 2124215-2010-23924
Event Type: Malfunction
Date Received: January 10, 2011
Date of Event: December 9, 2010
Report Date: March 7, 2011
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: NIK
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS EXPLANTED AND RETURNED FOR ANALYSIS.

Additional Manufacturer Narrative · 1

AS OF THIS REPORT, THE DEVICE HAS NOT BEEN RETURNED. WHEN THIS DEVICE GET'S RETURNED IT WILL BE ANALYZED.

Additional Manufacturer Narrative · 1

UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A VISUAL INSPECTION NOTED TOOLING MARKS ON THE HEADER SURFACE. THE DEVICE PASSED THERAPY VERIFICATION TESTING WHICH VERIFIED FUNCTIONALITY AND THERAPY DELIVERY. PORTIONS OF THE CIRCUITRY, INCLUDING THE BATTERY, WERE THEN ISOLATED AND TESTED. FINAL ANALYSIS CONCLUDED THAT THE PREMATURE BATTERY DEPLETION WAS DUE TO A COMPROMISED LOW-VOLTAGE CAPACITOR, WHICH RESULTED IN A HIGH CURRENT CONDITION.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) LAST MONTH. THE MONITORING VOLTAGE WAS 2.46 V AND CHARGE TIME WAS 11.5 SECONDS. APPROXIMATELY SIX MONTHS EARLIER THE VOLTAGE WAS AT 2.55. THE CALLER WAS CONCERNED THIS WAS A BIG DROP IN THAT TIME FRAME. TECHNICAL SERVICES DISCUSSED REPLACEMENT TIME AND NOTED IT IS UNKNOWN IF THIS DEVICE BATTERY DEPLETED EARLY. THE DEVICE IS SCHEDULED FOR EXPLANT AND WILL BE RETURNED FOR ANALYSIS. THIS DEVICE IS INCLUDED IN THE SHORTENED REPLACEMENT WINDOW ((B)(6) 2007) ADVISORY POPULATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CONTAK RENEWAL	IMPLANTABLE CHF GENERATOR	NIK	GUIDANT CRM CLONMEL IRELAND	H175

Patients

Seq	Age	Sex	Outcome	Treatment
1	50 YR			4513\| H135\| 0158\| H175\| 4470