BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY 2 DR EL

    MDR report key: 1041530 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-32003
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    October 24, 2007
    Report Date
    March 20, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z47/55-07
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 DR EL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T167 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other THE DEVICE 4470/510804 WAS IMPLANTED 12-MAY-2006| THE DEVICE 6949 LFJ137 WAS USED DURING THE EVENT.