BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK ENDURANCE RX

    MDR report key: 1043488 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33149
    Event Type
    Malfunction
    Date Received
    May 8, 2008
    Date of Event
    February 5, 2008
    Report Date
    February 5, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    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 ENDOTAK ENDURANCE RX IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0144 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other THE DEVICE 4053/403756 WAS IMPLANTED 03-MAR-2000| THE DEVICE A155/104212 WAS IMPLANTED 25-FEB-2004