VITALITY 2

MDR report key: 1861022 · Received October 7, 2010

Report

Report Number: 2124215-2010-15105
Event Type: Malfunction
Date Received: October 7, 2010
Date of Event: July 27, 2010
Report Date: August 4, 2010
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ANALYSIS OF THE RETURNED PRODUCT IS CURRENTLY ONGOING. THIS EVENT WILL BE UPDATED WHEN ANALYSIS IS COMPLETE.

Additional Manufacturer Narrative · 1

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 DEVICE DECLARED END OF LIFE (EOL) POST EXPLANT 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, ERI 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 (NOVEMBER 27, 2007) ADVISORY POPULATION. THIS ISSUE IS DISCUSSED IN THE Q2 2010 PRODUCT PERFORMANCE REPORT.

Description of Event or Problem · 1

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE WAS ELECTIVELY EXPLANTED DUE TO NORMAL BATTERY DEPLETION. THERE WERE NO ALLEGATIONS AGAINST THE DEVICE'S OPERATION, FUNCTIONALITY OR LONGEVITY. INITIAL LABORATORY ANALYSIS FOUND THE DEVICE DID NOT MEET LONGEVITY EXPECTATIONS PER PROGRAMMED VALUES.

Description of Event or Problem · 1

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VITALITY 2	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	GUIDANT CRM CLONMEL IRELAND	T167

Patients

Seq	Age	Sex	Outcome	Treatment
1	84 YR			0158\| 0041\| T167\| 4470\| 1600\| 1746\| 4320\| 0148