BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTAK PRIZM HE VR

    MDR report key: 1002419 · Received February 7, 2008

    Report

    Report Number
    2124215-2008-31882
    Event Type
    Injury
    Date Received
    February 7, 2008
    Date of Event
    October 6, 2006
    Report Date
    November 2, 2007
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRIZM HE VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC 1857 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention THE DEVICE 0064/001339 WAS IMPLANTED 10-MAY-1993