FDA Adverse Event Malfunction Summary report: N

VITALITY 2

MDR report key: 1771311 · Received July 27, 2010

Report

Report Number: 2124215-2010-12418
Event Type: Malfunction
Date Received: July 27, 2010
Date of Event: June 10, 2010
Report Date: July 9, 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

UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED IN AN ATTEMPT TO DETERMINE THE ROOT CAUSE OF THIS EVENT.

Additional Manufacturer Narrative · 1

UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, DEVICE INTERROGATION REVEALED THAT THE DEVICE BATTERY STATUS WAS ELECTIVE REPLACEMENT INDICATOR (ERI). 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 TWO COMPROMISED LOW VOLTAGE CAPACITORS, WHICH RESULTED IN A HIGH CURRENT CONDITION.

Description of Event or Problem · 1

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS DEVICE DECLARED ELECTIVE REPLACEMENT INDICATORS AFTER FIFTY-TWO MONTHS OF IMPLANT. THERE WAS CONCERN THAT THE BATTERY HAD DEPLETED MORE RAPIDLY THAN EXPECTED. A REPLACEMENT PROCEDURE WAS PERFORMED; THIS DEVICE WAS REMOVED, REPLACED AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Description of Event or Problem · 1

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Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VITALITY 2	IMPLANTABLE CARDIOVERTER DEFIBRILLATOR	LWS	GUIDANT CRM CLONMEL IRELAND	T165

Patients

Seq	Age	Sex	Outcome	Treatment
1