VITALITY 2

MDR report key: 1871630 · Received October 15, 2010

Report

Report Number: 2124215-2010-17568
Event Type: Malfunction
Date Received: October 15, 2010
Date of Event: August 30, 2010
Report Date: September 3, 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

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. THIS DEVICE IS PART OF THE EXPANDED MARCH 2009 POPULATION OF DEVICES DESCRIBED IN THE SHORTENED REPLACEMENT WINDOW ADVISORY. THIS ADVISORY WAS ORIGINALLY COMMUNICATED APRIL 5, 2007. THIS ISSUE IS DISCUSSED IN THE Q3 2010 PRODUCT PERFORMANCE REPORT.

Description of Event or Problem · 1

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION. 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	T175

Patients

Seq	Age	Sex	Outcome	Treatment
1	91 YR			T175\| 0158\| E102