BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRIZM HE VR

    MDR report key: 1253558 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40053
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    August 28, 2008
    Report Date
    September 11, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRIZM HE VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC 1852 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other THE DEVICE F030/200315 WAS IMPLANTED 28-AUG-2008