BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY

    MDR report key: 1954094 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-24021
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 13, 2010
    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

    VISUAL INSPECTION SHOWED A DENT IN THE BOTTOM FRONT OF THE DEVICE CASE. REVIEW OF DEVICE MEMORY SHOWED A CAPACITOR REFORMATION WAS DONE ONE WEEK BEFORE EXPLANT, YIELDING A CHARGE TIME OF 23 SECONDS AT A BATTERY VOLTAGE OF 2.56 VOLTS. THE DEVICE CASE WAS OPENED AND A CURRENT BATTERY MEASUREMENT OF 2.28 VOLTS WAS OBSERVED. VISUAL INSPECTION SHOWED A DENTED CAPACITOR THAT WAS ALIGNED WITH THE DENT IN THE CASE. A CAPACITOR REFORMATION WAS PERFORMED, AND THE DENTED CAPACITOR WOULD NOT CHARGE. THE CAPACITOR WAS CHECKED WITH AN OHM METER FOR ELECTRICAL RESISTANCE, AND SHOWED A SHORTED CONDITION. OUR ANALYSIS AND TESTING INDICATED THIS DEVICE AND CAPACITOR EXPERIENCED INDUCED DAMAGE AFTER EXPLANT, CAUSING THE DEVICE NOT TO CHARGE AND DELIVER ENERGY IN LABORATORY TESTING.

    Additional Manufacturer Narrative · 1

    INITIAL ANALYSIS AT OUR POST MARKET QUALITY ASSURANCE LABORATORY INDICATED THIS DEVICE DID NOT PASS A THERAPY AVAILABILITY TEST. 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 T125

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR T125| 4054| 0185