FDA Adverse Event Injury Summary report: N

VITALITY 2

MDR report key: 1861057 · Received October 7, 2010

Report

Report Number: 2124215-2010-15336
Event Type: Injury
Date Received: October 7, 2010
Date of Event: July 27, 2010
Report Date: August 27, 2010
Manufacturer: GUIDANT CRM CLONMEL IRELAND
Product Code: LWS
Removal / Correction Number: Z-1047-2007 TO Z-1055-20
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE WAS EXPLANTED, REPLACED, AND WILL BE RETURNED FOR ANALYSIS. THE POST MARKET QUALITY ASSURANCE LABORATORY WILL ANALYZE THE DEVICE. UPON COMPLETION OF THE ANALYSIS, THE REPORT WILL BE UPDATED.

Additional Manufacturer Narrative · 1

UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, A LONGEVITY CALCULATION CONFIRMED THAT THE DEVICE DID NOT MEET LONGEVITY ESTIMATES PROVIDED IN DEVICE LABELING. PORTIONS OF THE CIRCUITRY, INCLUDING THE BATTERY, WERE ISOLATED AND TESTED. ALL LOW VOLTAGE POWER SUPPLY MEASUREMENTS WERE CURRENTLY WITHIN AN APPROPRIATE RANGE; HOWEVER, FINAL ANALYSIS CONCLUDED THAT THE PREMATURE BATTERY DEPLETION WAS DUE TO LOW VOLTAGE CAPACITOR DEGRADATION, WHICH RESULTED IN A HIGH CURRENT CONDITION.

Description of Event or Problem · 1

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THERE WAS AN ALLEGATION OF PREMATURE BATTERY DEPLETION ON THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR. THE DEVICE WAS EXPLANTED AND NO ADVERSE EFFECTS WERE REPORTED. THIS DEVICE IS INCLUDED IN AN ADVISORY POPULATION IMPLICATED IN PREMATURE DEPLETION, SHORTENED REPLACEMENT WINDOW ((B)(6)2007).

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			Life Threatening\| R	T167\| MISMATCH\| F110\| 0161