BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXON ECLIPSE DIGITAL PREAMP

    MDR report key: 2891086 · Received December 20, 2012

    Report

    Report Number
    1045254-2012-00730
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Report Date
    September 22, 2011
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    GWF
    PMA / PMN Number
    K061639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT DATE 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 AND TO PROVIDE INFO TO DETERMINE THE STATE OF BLOOD FLOW IN THE INTRACRANIAL AND EXTRACRANIAL VASCULAR ARTERIES IN ADULTS. THE INSTRUMENT USES ELECTROENCEPHALOGRAPHY (EEG), ELECTROMYOGRAPHY (EMG), MOTOR AND SENSORY EVOKED POTENTIALS AND NERVE POTENTIALS AND DOPPLER ANALYSIS. IF THE SYSTEM FAILS TO PERFORM AS INTENDED, (SPECIALLY TO EFFECT OR DETECT ELECTROMYOGRAPHIC (EMG) ACTIVITY), IT PRESENT THE POTENTIAL FOR TEMPORARY OR PERMANENT DAMAGE TO THE NERVE THAT IS PRESENT. THERE ARE 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,CHARGE PER PULSE, CHARGE PER UNIT AREA, WAVEFORM MORPHOLOGY, REPETITION RATE, STIMULATOR EFFECTIVE SURFACE AREA. WHEN SUCH SITUATIONS OCCUR, THE SURGEON CAN ALSO FALSELY MISINTERPRET THAT A NERVE IS NOT PRESENT. THE NIM ECLIPSE SYSTEM WAS BUILT IN ALARMS AND WARNINGS TO ALERT USERS OF A SYSTEM FAILURE. AT THIS TIME WE ARE UNABLE TO CONFIRM WHETHER THE CUSTOMER WAS AWARE OF SUCH ALERTS. 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 AN ECLIPSE PREAMPLIFIER FOR "DROPS SIGNAL IN THE MIDDLE OF THE CASE." UPON RECEIPT OF THE DEVICE, TESTING AND REPAIR CONFIRMED THE REPORTED EVENT WHICH COULD HAVE 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. THE DEVICE WAS UPDATED TO CURRENT DESIGN SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXON ECLIPSE DIGITAL PREAMP GWF - STIMULATOR, ELECTRICAL, EVOKED RESPONSE GWF MEDTRONIC XOMED, INC. DAQ916 NA

    Patients

    Seq Age Sex Outcome Treatment
    1