BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXON PATIENT MODULE

    MDR report key: 2891136 · Received December 20, 2012

    Report

    Report Number
    1045254-2012-00739
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Report Date
    December 1, 2011
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    GWF
    PMA / PMN Number
    K050798
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF THIS REPORTED EVENT WAS NOT IDENTIFIED BY THE CUSTOMER. WHEN INFORMATION SUGGESTS THAT THE NIM ECLIPSE EQUIPMENT HAD THE POTENTIAL TO NOT STIMULATE 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 INFORMATION TO SUGGEST AN EVENT COULD NOT BE INTERPRETED FALSELY - THE REPORT IS INCONCLUSIVE AS TO THE CAUSE OF FIELD OBSERVATION. THEREFORE, WITHOUT INFORMATION TO REASONABLY SUGGEST SERIOUS INJURY, OR THAT MEDICAL INTERVENTION WAS REQUIRED TO PRECLUDE SERIOUS INJURY, WE ARE FILING THIS REPORT AS A PRODUCT PROBLEM. THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS. 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 DAMAGE TO THE NERVE THAT IS PRESENT. THE ECLIPSE PATIENT MODULE SERVES AS AN INTERFACE BETWEEN THE PT AND THE ECLC/CONTROLLER. IT IS DESIGNED TO DELIVER STIMULUS AND RECORD THE READINGS VIA ELECTRODES. THERE ARE ALSO MANY NON-DEVICE RELATED ISSUES THAT CAN CAUSE THE NIM ECLIPSE TO INDICATE NO STIMULATION OCCURRED OR NO ELECTRICAL RESPONSE WAS RECEIVED/DETECTED FROM THE MUSCLE; USE OF PARALYTIC ANESTHESIA AGENTS; TISSUES WERE TOO DRY, THE NERVE WAS FATIGUED BY OVERSTIMULATION. IN ADDITION, SAFE STIMULUS LEVELS ARE DEPENDENT UPON VARIOUS CONDITIONS INCLUDING BUT NOT LIMITED TO; TYPE OF EXCITABLE TISSUE, WAVEFORM MORPHOLOGY, REPETITION RATE, STIMULATOR CURRENT DELIVERED. WHEN SUCH SITUATIONS OCCUR, THE SURGEON CAN ALSO FALSELY MISINTERPRET THAT A NERVE IS NOT PRESENT. AT THIS TIME, WE ARE UNABLE TO CONFIRM WHETHER THE CUSTOMER RECEIVED ANY ERROR MESSAGES OR ALERTS OF THE FAULT. THIS REPORTED EVENT HAS NO REFERENCE TO AN ALARM OR WARNING, THEREFORE, IT MUST BE ASSUMED THAT AN ALARM OR WARNING WENT UNDETECTED OR DID NOT OCCUR.

    Description of Event or Problem · 1

    THE MANUFACTURER HAS CHANGED/IMPROVED THE CRITERIA FOR MAKING MDR DECISIONS REGARDING THE NERVE INTEGRITY MONITORING (NIM) ECLIPSE SYSTEM, PER DISCUSSION WITH OSB. A RETROSPECTIVE REVIEW FOUND THE FOLLOWING EVENT: A CUSTOMER RETURNED A PATIENT MODULE STATING THAT THE "NEEDLE PORTS ARE A PROBLEM (AND DO) NOT HAVE A GOOD CONNECTION. WHEN PUSHED IN TIGHTER, IT WILL WORK FOR A FEW SECONDS THEN PROBLEMS AGAIN." TESTING/REPAIR CONFIRMED THE REPORTED EVENT. THE REPORT OF AN INTERMITTENT CONDITION SUGGESTS A MALFUNCTION THAT COULD BE INTERPRETED AS A FALSE NEGATIVE IF IT WERE TO RECUR AND SYSTEM SAFE-GUARDS (WARNINGS/ALARMS) MAY NOT HAVE IDENTIFIED THE ISSUE. THERE WAS NO SUGGESTION OF PATIENT INJURY OR INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXON PATIENT MODULE GWF - STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF XOMED MFG JACKSONVILLE 945OPM660 NA

    Patients

    Seq Age Sex Outcome Treatment
    1