BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2 DR EL

    MDR report key: 1043329 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33325
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 8, 2008
    Report Date
    February 8, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z47/55-07
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY 2 DR EL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T167 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention THE DEVICE F030/200033 WAS IMPLANTED 08-FEB-2008| THE DEVICE 4480/455958 WAS IMPLANTED| THE DEVICE 0165/107904 WAS IMPLANTED