BEUDAMED
    FDA Adverse Event Death Summary report: N

    VITALITY 2 DR

    MDR report key: 1115152 · Received August 14, 2008

    Report

    Report Number
    2124215-2008-35097
    Event Type
    Death
    Date Received
    August 14, 2008
    Date of Event
    June 30, 2005
    Report Date
    May 12, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z47/55-07
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T165 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death THE DEVICE 1861/214526 WAS IMPLANTED 24-SEP-2001| THE DEVICE 4016/BIR204 WAS IMPLANTED 24-SEP-2001| THE DEVICE 0155/344979 WAS IMPLANTED 24-SEP-2001