BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 1771507 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12595
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    April 16, 2010
    Report Date
    June 11, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Removal / Correction Number
    Z-1047-2007 TO Z-1055-20
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT BOSTON SCIENTIFIC'S POST-MARKET QUALITY ASSURANCE LABORATORY, INITIAL ANALYSIS NOTED THAT THE DEVICE HAD NO TELEMETRY AND THAT A MEMORY DOWNLOAD COULD NOT BE PERFORMED. A VISUAL INSPECTION NOTED A SMALL DENT ON THE EDGE OF THE DEVICE CASE. THE CASING OF THE DEVICE WAS THEN REMOVED, AND DETAILED INSPECTION FOUND THAT A DEVICE CAPACITOR HAD BEEN DENTED. AN EXTERNAL POWER SUPPLY WAS THEN ATTACHED TO THE DEVICE, AND NO HIGH CURRENT CONDITION WAS IDENTIFIED. FIRMWARE WAS RELOADED AND THE DEVICE WAS PROGRAMMED OUT OF STORAGE MODE. THE BATTERY CURRENT DRAIN MEASUREMENT REMAINED WITHIN A NORMAL RANGE. ANALYSIS CONFIRMED THAT THE DEVICE WAS ABLE TO PACE, SENSE, CHARGE, AND DELIVER A FULL ENERGY SHOCK. THE LOSS OF TELEMETRY CONDITION WAS ATTRIBUTED TO A DEPLETED BATTERY. HOWEVER, THE ROOT CAUSE OF THE BATTERY DEPLETION COULD NOT BE DETERMINED AS DEVICE FUNCTION WAS NORMAL THROUGHOUT THE ANALYSIS. THIS EVENT WILL BE UPDATED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WAS EXPLANTED DUE TO THE PATIENT REQUIRING AN UPGRADE TO A CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D). NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS OBSERVATION, AND THE EXPLANTED DEVICE WAS RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR 4554| N119| T175| 5076| 0185