BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXON ECLIPSE CONTROLLER

    MDR report key: 3230163 · Received July 16, 2013

    Report

    Report Number
    1045254-2013-00459
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    GWF
    PMA / PMN Number
    K061639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. ALSO BEING USED WAS A COMPUTER (B)(4); LOT # AND SERIAL # WERE NOT PROVIDED, THEREFORE, WE CANNOT DETERMINE MANUFACTURE DATE. (B)(4). PRODUCT WILL NOT BE RETURNED FOR EVALUATION. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE IS WORKING INTERMITTENTLY. THE CUSTOMER AND OUR TECHNICIAN IN THE OR REPORTED THAT WHEN EXECUTING A TCEMEP STIMULUS THE TRACE DOESN'T GET THE INFORMATION THE FIRST TIME, BUT THEY CHECK THAT THE PATIENT IS MOVING BY THE APPLICATION OF THE ELECTRICAL STIMULATION. THE SECOND TIME THAT THEY EXECUTE THE TEST TCEMEP, THE TRACE CAPTURED THE ELECTRICAL ACTIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328570 AXON ECLIPSE CONTROLLER STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED, INC. ECLC 206878560

    Patients

    Seq Age Sex Outcome Treatment
    1