BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LD CV EZTRK 2 BP IS1 4542 80CM US

    MDR report key: 1042540 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-34103
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 4, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWP
    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 LD CV EZTRK 2 BP IS1 4542 80CM US IMPLANTABLE LEAD LWP CARDIAC PACEMAKERS, INC 4542 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other THE DEVICE 4554/155114 WAS IMPLANTED 04-MAR-2008| THE DEVICE 6949 LFJ140 WAS USED DURING THE EVENT.| THE DEVICE H217/700670 WAS IMPLANTED 01-FEB-2006