BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTAK PRIZM 2 VR

    MDR report key: 1254050 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40630
    Event Type
    Injury
    Date Received
    November 11, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 25, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    LAY USER/PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRIZM 2 VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC 1860 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention THE DEVICE 0157/124401 WAS IMPLANTED 21-SEP-2004| THE DEVICE 6481 058751 WAS USED DURING THE EVENT.| THE DEVICE 0157/126453 WAS IMPLANTED 21-SEP-2004