FDA Adverse Event Malfunction Summary report: N

VITALITY 2

MDR report key: 2162570 · Received July 14, 2011

Report

Report Number: 2124215-2011-06876
Event Type: Malfunction
Date Received: July 14, 2011
Date of Event: April 19, 2011
Report Date: April 28, 2011
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

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 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. THE DEVICE WAS THEN SUBJECTED TO, AND PASSED, A SERIES OF DIAGNOSTIC TESTS TO ASSESS THE PERFORMANCE OF DEFIBRILLATION, PACING, SENSING, HIGH VOLTAGE SHOCKING, AND DIAGNOSTIC RECORDING FUNCTIONS.

Additional Manufacturer Narrative · 1

THE DEVICE IS CURRENTLY UNDERGOING ANALYSIS. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED AND RETURNED FOR NORMAL BATTERY DEPLETION. NO FIELD ALLEGATIONS HAVE BEEN REPORTED AGAINST THIS PRODUCT. THIS REPORT WAS CREATED DUE TO INITIAL LABORATORY FINDINGS AS THIS PRODUCT DID NOT PASS LONGEVITY CALCULATIONS.

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	85 YR			0184\| 4469\| E110\| T167