VITALITY 2

MDR report key: 1944567 · Received January 3, 2011

Report

Report Number: 2124215-2010-19669
Event Type: Injury
Date Received: January 3, 2011
Date of Event: October 8, 2010
Report Date: November 10, 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 ANALYSIS, THIS EVENT WILL BE UPDATED.

Additional Manufacturer Narrative · 1

UPON RECEIPT AT OUR (B)(4) LABORATORY, DEVICE MEMORY WAS REVIEWED. WE CONFIRMED THAT THE DEVICE DECLARED EOL AFTER EXPERIENCING ONE CHARGE TIME GREATER THAN 30 SECONDS. TO DETERMINE IF THE DEVICE'S RATE OF BATTERY DEPLETION WAS NORMAL, OUR TECHNICIANS COMPARED THE OBSERVED RATE OF BATTERY USAGE TO THE EXPECTED RATE OF BATTERY USAGE. THE RESULTS SHOWED THAT THE MONITORING VOLTAGE WAS NORMAL BASED ON THERAPY USE TO DATE AND PROGRAMMED SETTINGS.] ALTHOUGH THE BATTERY ITSELF HAD NOT DEPLETED PREMATURELY, EOL WAS TRIGGERED EARLIER THAN EXPECTED BY CHARGE TIMES IN EXCESS OF THE 30 SECOND EOL CHARGE TIME LIMIT. LABORATORY TECHNICIANS AND ENGINEERS CONCLUDED THAT THIS DEVICE DID NOT EXPERIENCE PREMATURE BATTERY DEPLETION. RATHER, AN EOL CHARGE TIME REPLACEMENT INDICATOR WAS DECLARED DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF INTERNAL BATTERY IMPEDANCE.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) TRIGGERED END OF LIFE (EOL). PREMATURE BATTERY DEPLETION WAS ALLEGED. THE DEVICE WAS EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

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