BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2

    MDR report key: 2162532 · Received July 14, 2011

    Report

    Report Number
    2124215-2011-07053
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    April 20, 2011
    Report Date
    April 26, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    PMA / PMN Number
    P960040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS NOT BEEN RETURNED. IF RETURNED, OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL UPDATED.

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    INFORMATION WAS LATER RECEIVED THAT THIS DEVICE WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION. NO ADVERSE PATIENT EFFECTS WERE NOTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE CLINIC HAD NOT BEEN RECEIVING UPDATES FROM LATITUDE. IT WAS CONCLUDED THAT THE PATIENT'S COMMUNICATOR WAS UNPLUGGED. AFTER THE COMMUNICATOR WAS PLUGGED IN, AN UPLOAD WAS RECEIVED WITH MULTIPLE ALERTS. AN ALERT FOR ELECTIVE REPLACEMENT INDICATOR (ERI) AND END OF LIFE (EOL) WERE RECEIVED. EOL WAS TRIPPED 60 DAYS AFTER ERI. AS THE DEVICE IS BEYOND THE ERI TO EOL REPLACEMENT WINDOW, IT WAS RECOMMENDED THAT THE DEVICE BE REPLACED AS SOON AS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND T165

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR 6949| 4473| T165