BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2 VR

    MDR report key: 1043088 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33561
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 5, 2008
    Report Date
    February 5, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z47/55-07
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T175 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention THE DEVICE 0185/124719 WAS IMPLANTED 30-NOV-2005| THE DEVICE 4137/282384 WAS IMPLANTED 04-FEB-2008| THE DEVICE 4137/245300 WAS IMPLANTED 05-FEB-2008