BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 3

    MDR report key: 1043506 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33139
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    January 31, 2008
    Report Date
    January 31, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 3 IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4525 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other THE DEVICE 0185/109595 WAS IMPLANTED 19-OCT-2004| THE DEVICE H217/711676 WAS IMPLANTED 31-JAN-2008| THE DEVICE H175/507474 WAS IMPLANTED 19-OCT-2004| THE DEVICE 4543/130560 WAS IMPLANTED 31-JAN-2008