BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY AVT FAST-CHARGE

    MDR report key: 1041636 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-31914
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    July 8, 2005
    Report Date
    January 22, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z47/53-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY AVT FAST-CHARGE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC A155 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other THE DEVICE 4086/215629 WAS IMPLANTED 07-JAN-2005| THE DEVICE 0184/103810 WAS IMPLANTED 07-JAN-2005