BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 1043378 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33263
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 7, 2008
    Report Date
    February 7, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4517 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other THE DEVICE 6482 006155 WAS USED DURING THE EVENT.| THE DEVICE H219/200677 WAS IMPLANTED 18-JAN-2006| THE DEVICE 6482 002863 WAS USED DURING THE EVENT.| THE DEVICE 4053/415086 WAS IMPLANTED 18-JAN-2006| THE DEVICE 6483 505100 WAS USED DURING THE EVENT.| THE DEVICE 0157/130542 WAS IMPLANTED 18-JAN-2006| THE DEVICE 6487 505100 WAS USED DURING THE EVENT.