BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITALITY DR HE

    MDR report key: 1043009 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33622
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 18, 2008
    Report Date
    February 18, 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 DR HE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T180 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other THE DEVICE 0158/166408 WAS IMPLANTED 20-SEP-2006| THE DEVICE 4053/416438 WAS IMPLANTED 08-MAY-2006| THE DEVICE 4035/340354 WAS IMPLANTED 08-MAY-2006| THE DEVICE 6481 050952 WAS USED DURING THE EVENT.