BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTAK PRIZM 2 DR

    MDR report key: 1042330 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34313
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    March 11, 2008
    Report Date
    March 11, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    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 2 DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC 1861 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention THE DEVICE LATR WAS USED DURING THE EVENT.| THE DEVICE 0158/123209 WAS IMPLANTED 08-OCT-2003| THE DEVICE 6481 003501 WAS USED DURING THE EVENT.| THE DEVICE 4054/427797 WAS IMPLANTED 08-OCT-2003