BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 1042465 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34168
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 6, 2008
    Report Date
    March 6, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EASYTRAK 2 IMPLANTABLE LEAD DTB CARDIAC PACEMAKERS, INC 4518 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other THE DEVICE 6481 042535 WAS USED DURING THE EVENT.| THE DEVICE 4017/BIT268 WAS IMPLANTED 11-OCT-2004| THE DEVICE 0185/109552 WAS IMPLANTED 11-OCT-2004| THE DEVICE H179/501413 WAS IMPLANTED 11-OCT-2004| THE DEVICE LATR WAS USED DURING THE EVENT.