FDA Adverse Event Malfunction Summary report: N

VITALITY

MDR report key: 2780445 · Received October 10, 2012

Report

Report Number: 2124215-2012-12574
Event Type: Malfunction
Date Received: October 10, 2012
Date of Event: July 6, 2011
Report Date: September 17, 2012
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A REVIEW OF DEVICE MEMORY REVEALED THAT THE DEVICE DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) AFTER EXPERIENCING TWO CONSECUTIVE CHARGE TIMES GREATER THAN THE EXTENDED MID-LIFE ERI CHARGE TIME LIMIT. 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, ERI WAS TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES DUE TO A HIGHER-THAN-TYPICAL BUILDUP OF INTERNAL BATTERY IMPEDANCE.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT WHILE THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS IMPLANTED, IT SHOWED AN EXTENDED CHARGE TIME. THERE WAS NO ALLEGATION OF PREMATURE BATTERY DEPLETION. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED FOR A LONGEVITY ESTIMATE AND TS RECOMMENDED TO FOLLOW THE RECOMMENDATIONS PROVIDED IN DEVICE LABELING FOR FOLLOW-UPS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. OVER A YEAR LATER, THIS ICD WAS RETURNED FOR DISPOSAL ONLY, WITH NO REPORTED PRODUCT PERFORMANCE ISSUES AND NO REPORTED ADVERSE PATIENT EFFECTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VITALITY	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	GUIDANT CRM CLONMEL IRELAND	T135

Patients

Seq	Age	Sex	Outcome	Treatment
1	88 YR			T135\| 0185