FDA Adverse Event Malfunction Summary report: N

CONTAK RENEWAL

MDR report key: 2173759 · Received July 24, 2011

Report

Report Number: 2124215-2011-11623
Event Type: Malfunction
Date Received: July 24, 2011
Date of Event: August 25, 2007
Report Date: June 17, 2011
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: NIK
Removal / Correction Number: Z-0047-08 TO Z-0053-08
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, THIS DEVICE WAS HELD DUE TO PENDING LITIGATION. RECENTLY THE LEGAL CASE HAS BEEN SETTLED AND THE DEVICE WAS FORWARDED FOR ANALYSIS. A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED END OF LIFE (EOL) AFTER EXPERIENCING ONE CHARGE TIME GREATER THAN 30 SECONDS. THE OBSERVED RATE OF BATTERY USAGE WAS COMPARED TO THE EXPECTED RATE OF BATTERY USAGE; THE RESULTS INDICATED THAT THE MONITORING VOLTAGE WAS NORMAL. ALTHOUGH THE BATTERY ITSELF HAD NOT DEPLETED PREMATURELY, EOL WAS TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE. THIS DEVICE IS INCLUDED IN THE MID-LIFE DISPLAY OF REPLACEMENT INDICATORS ((B)(6), 2007) ADVISORY POPULATION.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS EXHIBITING BEEP TONES. A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) CONSULTANT DISCUSSED THE POSSIBLE CAUSES OF BEEP TONES AND RECOMMENDED THAT THE PATIENT FOLLOW UP WITH THEIR PHYSICIAN. THE DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION. NO ADVERSE PATIENT SYMPTOMS WERE REPORTED. UPON ITS RETURN, THIS DEVICE WAS HELD DUE TO PENDING LITIGATION.

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	70 YR			4470\| 0185\| 4513\| H175