BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 2040779 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00834
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RETURN TO BOSTON SCIENTIFIC'S POST MARKET QUALITY ASSURANCE LABORATORY, A REVIEW OF DEVICE MEMORY REVEALED THE DEVICE DECLARED ITS ELECTIVE REPLACEMENT INDICATOR (ERI) AFTER EXPERIENCING TWO CONSECUTIVE CHARGE TIMES GREATER THAN THE EXTENDED MID-LIFE ERI CHARGE TIME LIMIT. ADDITIONAL LAB ANALYSIS AND TESTING SHOWED ERI WAS TRIGGERED EARLIER THAN EXPECTED BY EXTENDED CHARGE TIMES DUE TO A HIGHER-THAN-TYPICAL BUILD-UP OF DEVICE INTERNAL BATTERY IMPEDANCE. THE EOL (END OF LIFE) INDICATOR WAS NOT DECLARED WHILE THE DEVICE WAS IN SERVICE. TESTING CONFIRMED ALL DEVICE THERAPIES WERE AVAILABLE.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T135

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR T135| 0185