BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTAK MINI IV

    MDR report key: 1042194 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34457
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 16, 2008
    Report Date
    March 16, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    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 MINI IV IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS CARDIAC PACEMAKERS, INC 1790 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other THE DEVICE 0125/313970 WAS IMPLANTED 06-NOV-1998| THE DEVICE 0125/312857 WAS IMPLANTED 17-SEP-1998| THE DEVICE 1782/ WAS IMPLANTED