BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY EL

    MDR report key: 1042943 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33696
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 20, 2008
    Report Date
    February 20, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z47/53-08
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITALITY EL IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC T127 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention THE DEVICE 4086/203514 WAS IMPLANTED 13-NOV-2003| THE DEVICE 6481 027127 WAS USED DURING THE EVENT.| THE DEVICE 0157/112559 WAS IMPLANTED 13-NOV-2003