BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK PRIZM 2 DR

    MDR report key: 1041551 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-31996
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    October 9, 2007
    Report Date
    January 7, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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 Other THE DEVICE 0154/360243 WAS IMPLANTED 02-NOV-2007| THE DEVICE 1871/108655 WAS IMPLANTED 02-NOV-2007| THE DEVICE 0154/358820 WAS IMPLANTED 18-NOV-2004