BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYTRAK 2

    MDR report key: 1253568 · Received November 11, 2008

    Report

    Report Number
    2124215-2008-40075
    Event Type
    Malfunction
    Date Received
    November 11, 2008
    Date of Event
    August 29, 2008
    Report Date
    August 29, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWP
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other THE DEVICE 0175/108147 WAS IMPLANTED 03-MAY-2005| THE DEVICE 4064/314141 WAS IMPLANTED 03-MAY-2005| THE DEVICE 4518/332070 WAS IMPLANTED 29-AUG-2008| THE DEVICE H215/709682 WAS IMPLANTED 11-JAN-2008