BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTAK PRIZM 2 DR

    MDR report key: 1253816 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40472
    Event Type
    Injury
    Date Received
    November 11, 2008
    Date of Event
    August 25, 2008
    Report Date
    September 11, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    Z0906-05
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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 85 YR Required Intervention THE DEVICE 4087/150846 WAS IMPLANTED 22-OCT-2002| THE DEVICE 0148/118886 WAS IMPLANTED 22-OCT-2002