BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTAK PRIZM HE DR

    MDR report key: 1041953 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34692
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 21, 2008
    Report Date
    March 21, 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 VENTAK PRIZM HE DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC 1853 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention THE DEVICE 0125/227207 WAS IMPLANTED 18-DEC-1997| THE DEVICE 1861/238584 WAS IMPLANTED 20-FEB-2003| THE DEVICE 1810/304068 WAS IMPLANTED 18-DEC-1997| THE DEVICE 4269/283829 WAS IMPLANTED 18-DEC-1997