BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK

    MDR report key: 1041623 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-31902
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    October 30, 2003
    Report Date
    February 8, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4512 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other THE DEVICE 0158/121778 WAS IMPLANTED 15-AUG-2003| THE DEVICE H175/100779 WAS IMPLANTED 15-AUG-2003| THE DEVICE 4470/360343 WAS IMPLANTED 15-AUG-2003