BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXON ECLIPSE CONTROLLER

    MDR report key: 2883023 · Received December 18, 2012

    Report

    Report Number
    1045254-2012-00722
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Report Date
    September 7, 2011
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    GWF
    PMA / PMN Number
    K061639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. ELECTRICAL TESTS PERFORMED. ANALYSIS OF LABELING PERFORMED. WHEN INFO 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 INFO TO SUGGEST AN EVENT COULD NOT BE INTERPRETED FALSELY - THE REPORT IS INCONCLUSIVE AS TO THE CAUSE OF THE FIELD OBSERVATION. THEREFORE, WITHOUT INFO 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 SYS 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 ECLC ECLIPSE SYSTEM CONTROLLER PROVIDES HIGH SPEED DIGITAL DATA PROCESSING, STIMULATION GENERATION AND AUDIO PROCESSING OF EMG ACTIVITY AND ALSO SUPPLIES SWITCHED AC POWER TO COMPUTER. THE CONTROLLER CONNECTS TO THE COMPUTER VIA THE HIGH SPEED PCMCIA INTERFACE. 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, STIMULATION CURRENT DELIVERED. WHEN SUCH STIMULATIONS 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 MFR HAS CHANGED/IMPROVED THE CRITERIA FOR MAKING MDR DECISIONS REGARDING THE NERVE INTEGRITY MONITORING (NIM) ECLIPSE SYSTEM, PER DISCUSSION WITH (B)(6). A RETROSPECTIVE REVIEW FOUND THE FOLLOWING EVENT: A CUSTOMER RETURNED AN ECLIPSE CONTROLLER FOR AN "ELECTRICAL STIM MODULE FAILURE." TESTING/REPAIR CONFIRMED THE REPORTED EVENT AND REPLACED THE STIMULATION BOARD AND CONNECTORS. A FAILED STIMULATION BOARD HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO PT INJURY (LOSS OF STIMULATION DURING USE LEADING TO A FALSE NEGATIVE) - AS A SUDDEN FAILURE MAY NOT BE CONSISTENTLY ACCOMPANIED BY WARNING/ERROR MESSAGES DURING A PROCEDURE. THERE WAS NO SUGGESTION OF PT INJURY OR INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXON ECLIPSE CONTROLLER GWF - STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF XOMED MFG JACKSONVILLE ECLC NA

    Patients

    Seq Age Sex Outcome Treatment
    1