BEUDAMED
    FDA Adverse Event Death Summary report: N

    VITALITY DR HE

    MDR report key: 1041557 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-31974
    Event Type
    Death
    Date Received
    May 8, 2008
    Date of Event
    August 9, 2007
    Report Date
    February 11, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    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 44 YR Death THE DEVICE 0158/147555 WAS IMPLANTED 17-DEC-2004| THE DEVICE H179/505085 WAS IMPLANTED 17-DEC-2004