BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 2040674 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00540
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 7, 2011
    Report Date
    January 12, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE MEMORY REVEALED THE DEVICE DECLARED ITS END OF LIFE INDICATOR (EOL) AFTER EXPERIENCING A CHARGE TIME GREATER THAN THE EXTENDED MID-LIFE EOL 30-SECOND CHARGE TIME LIMIT. ADDITIONAL LAB ANALYSIS AND TESTING SHOWED EOL WAS TRIGGERED EARLIER THAN EXPECTED BY AN EXTENDED CHARGE TIME DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF DEVICE INTERNAL BATTERY IMPEDANCE. ANALYSIS CONFIRMED THAT ALL THERAPIES WERE AVAILABLE.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, REVIEW OF DEVICE MEMORY SHOWED THE DEVICE HAD DECLARED END OF LIFE (EOL) BATTERY STATUS WITHOUT HAVING PREVIOUSLY DECLARED ELECTIVE REPLACEMENT INDICATOR (ERI) STATUS, THUS A LONGEVITY CALCULATION COULD NOT BE PERFORMED. ADDITIONAL ANALYSIS IS PENDING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION. THERE WERE NO KNOWN ALLEGATIONS AGAINST THE DEVICE, AND NO REPORTS OF ADVERSE PATIENT EFFECTS.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T180

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR 0158| T180