BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 2040891 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01471
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 10, 2011
    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, 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. 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 RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS REMOVED AND REPLACED FOR AN UNSPECIFIED REASON. INITIAL ROUTINE ANALYSIS TESTING OF THE DEVICE REVEALED THAT THE DEVICE HAD TRIGGERED THE TRIGGERED INDICATOR WHILE IMPLANTED; HOWEVER, THE DEVICE FAILED THE LABELED LONGEVITY CALCULATION. IN ADDITION, THE DEVICE WAS INCLUDED IN THE SHORTENED REPLACEMENT WINDOW ADVISORY (B)(6) 2007 POPULATION PRODUCT ADVISORY. THE DEVICE WAS FORWARDED ON FOR FURTHER DETAILED ANALYSIS TESTING. NO ADVERSE PATIENT EFFECTS WERE 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 34 YR Other 0165| T177