BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY AVT FAST-CHARGE

    MDR report key: 1043463 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33180
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 8, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z47/53-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    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 58 YR Other THE DEVICE 4470/444388 WAS IMPLANTED 21-JAN-2005| THE DEVICE T165/137087 WAS IMPLANTED 01-FEB-2008| THE DEVICE 0185/112391 WAS IMPLANTED 21-JAN-2005