BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXON ECLIPSE CONTROLLER

    MDR report key: 3491950 · Received November 27, 2013

    Report

    Report Number
    1045254-2013-00580
    Event Type
    Malfunction
    Date Received
    November 27, 2013
    Date of Event
    November 4, 2013
    Report Date
    November 6, 2013
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    GWF
    PMA / PMN Number
    K050798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT PRODUCTS: COMPUTER 945NCCPU NOTEBOOK, SERIAL # (B)(4), LOT # 205832114, MFG DATE 4/18/2012, K050798. EXTENDER 945EEX901 STIMULATOR, SERIAL # (B)(4), LOT # 205843474, MFG DATE 5/1/2012, K050798. EXTENDER 945EEX901 STIMULATOR, SERIAL # (B)(4), LOT # 205844153, MFG DATE 5/1/2012, K050798. AMPLIFIER 945DAQ916 DIG PREAMPLIFIER, SERIAL # (B)(4), MFG DATE 5/13/2011, K050798. AMPLIFIER 945DAQ916 DIG PREAMPLIFIER, SERIAL # (B)(4), MFG DATE 5/13/2011, K050798. MODULE 945OPM660 PATIENT, SERIAL #(B)(4), MFG DATE 5/18/2011, K050798 (B)(4). DEVICE CODE: DEVICE OPERATES DIFFERENTLY THAN EXPECTED. THE RETURNED DEVICES WERE EVALUATED: NO FAULT WAS FOUND, THE ITEM TESTED TO SPECIFICATIONS. THE ITEM WAS UPGRADED TO CURRENT SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SYSTEM FREEZES AND REQUIRES A HARD RESET, AS WELL AS THE SSEP STIM PARAMETERS HAD CHANGED AND STIMULATION WAS NOT BEING DELIVERED TO THE PATIENT. THE USER WAS NOT ALERTED BY THE MACHINE, BUT HE NOTICED HIS SIGNALS WERE NOT AVERAGING SO HE BEGAN TO TROUBLESHOOT. HE NOTICED THAT THE PATIENT WAS NO LONGER TWITCHING FROM STIMULATION WHICH LED HIM TO BELIEVE THAT NO STIMULUS WAS BEING DELIVERED, EVEN THOUGH HE HAD A FULL 4/4 TWITCHES. SO, WHEN HE STARTED GOING THROUGH ALL OF HIS PARAMETERS, THAT¿S WHEN HE NOTICED THAT THE SETTINGS HAD BEEN CHANGED WITHOUT DOING ANYTHING TO THEM ON HIS END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620996 AXON ECLIPSE CONTROLLER STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED, INC. 945ECLC 205843836

    Patients

    Seq Age Sex Outcome Treatment
    1