BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTAK PRIZM HE DR

    MDR report key: 1042939 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33692
    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
    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 72 YR Required Intervention THE DEVICE 0185/119471 WAS IMPLANTED 13-APR-2005| THE DEVICE 4470/466055 WAS IMPLANTED 13-APR-2005