BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 1042040 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34611
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 14, 2008
    Report Date
    March 14, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    DTB
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    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 71 YR Other THE DEVICE H175/507920 WAS IMPLANTED 02-MAR-2005| THE DEVICE 4402/BIU355 WAS IMPLANTED 08-APR-2008| THE DEVICE 6949 LFJ056 WAS USED DURING THE EVENT.| THE DEVICE 4555/162892 WAS IMPLANTED 14-MAR-2008| THE DEVICE 4538/164759 WAS IMPLANTED 14-MAR-2008