BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXON DIGITAL PREAMPLIFIER

    MDR report key: 3012884 · Received March 1, 2013

    Report

    Report Number
    1045254-2013-00193
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    May 25, 2012
    Report Date
    June 4, 2012
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    GWF
    PMA / PMN Number
    K50798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING FOUND THAT THE "UNIT DID NOT TURN ON THREE TRACES (10,14 AND 15)" - THE MIDDLE CIRCUIT BOARD WAS REMOVED/REPLACED. THE CASE WAS ALSO BROKEN; THE CASE AND HARDWARE WERE REPLACED. THE NIM-ECLIPSE SYSTEM NEUROVASCULAR WORKSTATION IS INTENDED FOR USE TO MONITOR SENSORY AND MOTOR PATHWAYS. IF THE SYSTEM FAILS TO PERFORM AS INTENDED, (ESPECIALLY TO EFFECT OR DETECT ELECTROMYOGRAPHIC (EMG) ACTIVITY) IT PRESENTS THE POTENTIAL FOR TEMPORARY OR PERMANENT DAMGE TO THE NERVE THAT IS PRESENT. THE DIGITAL AMPLIFIER IS DESIGNED TO PROVIDE SIGNAL DETECTION, AMPLIFICATION, MONTAGE SELECTION, A/D CONVERSION, ANTI-ALIASING FILTERING, AND DIGITAL SIGNAL PREPROCESSING. ISOLATED DIGITAL DATA IS ROUTED TO THE CONTROLLER FOR FURTHER PROCESSING. WHEN INFO SUGGESTS THAT THE NIM ECLIPSE EQUIPMENT HAD THE POTENTIAL TO NOT SIMULATE TO AFFECT ELECTROMYOGRAPHY (EMG), OR TO DETECT EMG, IT IS ASSUMED THAT THE FAILURE WAS DEVICE-RELATED AND MAY HAVE GONE UNDETECTED. IN THIS CASE, THERE IS NO INFO TO SUGGEST AN EVENT COULD NOT BE INTERPRETED FALSELY - THE REPORT IS INCONCLUSIVE AS TO THE CAUSE OF FIELD OBSERVATION. THEREFORE, WITHOUT INFO TO REASONABLY SUGGEST SERIOUS INJURY, OR THAT MEDICAL INTERVENTION WAS REQUIRED TO PRECLUDE SERIOUS INJURY, WE ARE FILLING THIS REPORT AS A PRODUCT PROBLEM. THIS PRODUCT WAS BEING USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 1

    THE MFR HAS REFINED THE CRITERIA FOR MAKING MDR DECISIONS. UPON A RETROSPECTIVE REVIEW, THE FOLLOWING EVENT IS NOW BELIEVED TO BE REPORTABLE. THE DEVICE WAS RETURNED FOR SVC/ REPAIR INDICATING THAT IT WAS NOT FUNCTION PROPERLY INTRA-OPERATIVELY. IT WAS REPORTED THAT THE DEVICE HAD THE SAME ISSUE IN THREE SEPARATE CASES OVER TWO CONSECUTIVE DAYS. (ALTHOUGH NO INFO WAS OBTAINED BY THE MFR TO DISTINGUISH EACH EVENT, THREE SEPARATE MDRS ARE BEING FILE). THERE WAS NO SUGGESTION OF PT INJURY. HOWEVER, AN ALLEGATION OF NOT WORKING PROPERTY MAY SUGGEST A POTENTIAL INABILITY TO IDENTIFY A NERVE AND COULD POSSIBLY RESULT IN PT INJURY, I.E. NERVE RESECTION BY THE SURGEON. THIS REPORTED EVENT HAS REFERENCE TO AN ALARM OR WARNING, THEREFORE, IT MUST BE ASSUMED THAT AN ALARM OR WARNING WENT UNDETECTED OR DID NOT OCCUR. NO OTHER INFO WAS PROVIDED. AT THIS TIME WE ARE UNABLE TO CONFIRM WHETHER THE CUSTOMER REC'D ANY ERROR MESSAGES OR ALERTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89984 AXON DIGITAL PREAMPLIFIER GWF - STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED, INC. 945DAQ916 0205848122

    Patients

    Seq Age Sex Outcome Treatment
    1