BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2 VR EL

    MDR report key: 1041874 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34768
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 21, 2008
    Report Date
    February 21, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 VR EL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T177 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention THE DEVICE 0158/138565 WAS IMPLANTED 03-MAY-2004| THE DEVICE T135/935856 WAS IMPLANTED 03-MAY-2004