BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTAK PRIZM 2 DR

    MDR report key: 1041453 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-32093
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    January 2, 2008
    Report Date
    January 2, 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
    OTHER HEALTH CARE PROFESSIONAL

    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 66 YR Required Intervention THE DEVICE 6481 027077 WAS USED DURING THE EVENT.| THE DEVICE 0158/122710 WAS IMPLANTED 17-OCT-2003| THE DEVICE 4470/370434 WAS IMPLANTED 17-OCT-2003