BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXON ECLIPSE CONTROLLER

    MDR report key: 3495269 · Received December 2, 2013

    Report

    Report Number
    1045254-2013-00581
    Event Type
    Malfunction
    Date Received
    December 2, 2013
    Date of Event
    November 6, 2013
    Report Date
    November 7, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    GWF
    PMA / PMN Number
    K061639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT MEDICAL PRODUCT: 945DAQ915: AMPLIFIER DIG PREAMPLIFIER, (B)(4), MFG DATE UNKNOWN, GWF, K061639. CONCOMITANT MEDICAL PRODUCT: 945DAQ915: AMPLIFIER DIG PREAMPLIFIER, SERIAL # (B)(4), MFG DATE UNKNOWN, GWF, K061639. (B)(6). (B)(4). THE RETURNED DEVICES WERE REVIEWED: COULD NOT DUPLICATE CUSTOMER¿S ISSUE. NO FAULT WAS FOUND. ISSUE WAS CONFIRMED, THE UNIT WAS NOT WORKING PROPERLY AND HAD AN EXCESSIVE HEAT DUE TO COMPONENTS ON BOTTOM AND FRONT END BOARDS WERE SHORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE CONTROL BOX HAD A POSSIBLE SHORT - WHILE THE PREAMPS WERE BEING USED WITH THE CONTROLLER, THEY WERE RUNNING HOT. THERE WERE NO IMPEDANCE TEST RESULTS. ADDITIONAL INFORMATION PROVIDED BY THE FACILITY TECH INDICATED THE DAQS WERE HOT TO THE TOUCH, AND THE USER COULD VISUALLY SEE THEY WERE STIMULATING THE NERVE, BUT THERE WAS NO RESPONSE FROM THE SYSTEM. NO READINGS ON THE MONITOR. THE TECH WAS NOT AWARE IF THE USER RECEIVED ANY MESSAGES OR ALERTS FROM THE SYSTEM. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623419 AXON ECLIPSE CONTROLLER STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED, INC. 945ECLC

    Patients

    Seq Age Sex Outcome Treatment
    1