BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALITY 2 DR EL

    MDR report key: 1043579 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33072
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 1, 2008
    Report Date
    February 1, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    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 60 YR Required Intervention THE DEVICE 0184/143002 WAS IMPLANTED 11-JAN-2008| THE DEVICE T165/107213 WAS IMPLANTED 21-JUN-2005| THE DEVICE 1763/801778 WAS IMPLANTED 10-FEB-1997| THE DEVICE 4088/104848 WAS IMPLANTED 16-MAY-2002| THE DEVICE 0095/202043 WAS IMPLANTED 10-FEB-1997| THE DEVICE 0148/119376 WAS IMPLANTED 16-MAY-2002| THE DEVICE 1851/401389 WAS IMPLANTED 16-MAY-2002