BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 3211350 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08718
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 16, 2013
    Report Date
    June 3, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DETAILED ANALYSIS IS BEING PERFORMED ON THIS DEVICE. UPON COMPLETION OF ANALYSIS, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY VISUAL INSPECTION NOTED THAT ALL THE SEAL PLUGS WERE INTACT AND SETSCREWS WERE OPERATING NORMALLY. THE DEVICE CASE APPEARED TO BE SWOLLEN. THE DEVICE HAD NO TELEMETRY AND NO PACEMAKER OUTPUT. THE GENERATOR CASING WAS REMOVED AND NO IRREGULARITIES WERE NOTED. MANUAL ELECTRICAL MEASUREMENTS WERE TESTED AND THERE WAS NORMAL SENSING, PACING AND DEFIBRILLATOR FUNCTIONALITY. A DEPLETED CELL WAS THE CAUSE OF THE NO TELEMETRY, AND THERE IS NO KNOWN CAUSE FOUND FOR HOW THE CELL DEPLETED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE DID NOT PASS A PORTION OF THE RETURNED PRODUCTS TESTING, SUGGESTING A POSSIBLE PERFORMANCE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310117 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T175

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR T175| 0185