BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2

    MDR report key: 1950646 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-24467
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, ICD MEMORY WAS REVIEWED. WE CONFIRMED THAT THE DEVICE DECLARED EOL AFTER EXPERIENCING ONE CONSECUTIVE CHARGE TIMES GREATER THAN THE 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) WAS EXPLANTED DUE TO HAVING REACHED END OF LIFE (EOL). THERE WAS CONCERN THIS ICD DEPLETED EARLIER THAN EXPECTED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T177

    Patients

    Seq Age Sex Outcome Treatment
    1