BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVICE 8252410 NIM-NEURO 2.0 INTERFACE

    MDR report key: 2802463 · Received October 18, 2012

    Report

    Report Number
    1045254-2012-00480
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Report Date
    November 3, 2011
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    ETN
    PMA / PMN Number
    K024316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING CONFIRMED FUSE FAILURE (THE FUSE WAS BLOWN) IN THE PATIENT INTERFACE. FUSE FAILURE HAS THE POTENTIAL TO CONTRIBUTE TO NOT RECOGNIZING A NERVE THAT IS PRESENT (FALSE NEGATIVE). THIS PATIENT INTERFACE WAS RETURNED WITH A NIM MAINFRAME AND AS THESE DEVICES CANNOT OPERATE INDEPENDENTLY OF EACH OTHER, THEY ARE BEING REPORTED AS A SYSTEM. THE PATIENT INTERFACE SERVES AS A JUNCTION FOR ELECTRODES AND CABLES BETWEEN THE PATIENT AND THE MAINFRAME. THE MAINFRAME HAS BUILT IN AUDIO AND VISUAL WARNINGS TO ALERT THE USER OF A SYSTEM FAILURE AND IT IS UNKNOWN IF THE USER RECEIVED AUDIO OR VISUAL ALERTS FOR THIS EVENT. A MUTING PROBE WAS ALSO RETURNED, BUT UNLIKE THE INTERFACE AND MAINFRAME, IT IS NOT ESSENTIAL TO THE FUNCTIONALITY OF THE NIM SYSTEM, AND DOES NOT HAVE THE POTENTIAL TO CAUSE A FALSE NEGATIVE. WHEN INFORMATION SUGGESTS THAT THE NIM 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. SINCE FUSE FAILURE CAN CAUSE OR CONTRIBUTE TO FALSE NEGATIVE (FAILURE TO LOCATE NERVE) AND 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 SYSTEM IS INTENDED FOR LOCATING AND IDENTIFYING CRANIAL AND PERIPHERAL MOTOR AND MIXED MOTOR-SENSORY NERVES DURING SURGERY, INCLUDING SPINAL CORD AND SPINAL NERVE ROOTS. IF THE SYSTEM FAILS TO PERFORM AS INTENDED, (EFFECT OR DEFECT ELECTROMYOGRAPHIC (EMG) ACTIVITY) IT PRESENTS 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 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 AND STIMULATOR EFFECTIVE SURFACE AREA. WHEN SUCH SITUATIONS OCCUR, THE SURGEON CAN ALSO FALSELY MISINTERPRET THAT A NERVE IS NOT PRESENT. THE NIM SYSTEM HAS 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 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) SYSTEM, PER DISCUSSION WITH OSB. WHEN INFORMATION SUGGESTS THAT THE NIM EQUIPMENT HAD THE POTENTIAL TO NOT STIMULATE TO AFFECT ELECTROMYOGRAPHY (EMG), OR TO DETECT EMG, THIS RETROSPECTIVE REVIEW (WITHOUT THE BENEFIT OF ADDITIONAL INFORMATION) ASSUMES THAT THE FAILURE WAS DEVICE-RELATED AND MAY HAVE GONE UNDETECTED. A CUSTOMER RETURNED A NIM-RESPONSE 2.0 NERVE MONITORING SYSTEM, WHICH INCLUDES THE PATIENT INTERFACE, THE MUTING DETECTOR PROBE AND THE NIM 2.0 MAINFRAME FOR EVALUATION/REPAIR COMMENTING: "DEVELOPED PROBLEMS DURING A CASE." NO PATIENT INJURY WAS REPORTED. TESTING CONFIRMED THAT THERE FUSE FAILURE, WHICH HAS TO POTENTIAL TO CONTRIBUTE TO NOT RECOGNIZING A NERVE THAT IS PRESENT (FALSE NEGATIVE). BLOWN FUSES HAVE THE POTENTIAL TO GO UNDETECTED AND ALTHOUGH THE NIM SYSTEM HAS BUILT IN ALARMS, BOTH VISUAL AND AUDIBLE, TO ALERT USERS TO CONDITIONS WHICH PREVENT PROPER MONITORING, IT IS UNCLEAR IF ANY SUCH WARNINGS WERE IDENTIFIED IN THIS REPORTED EVENT. THERE WAS NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEVICE 8252410 NIM-NEURO 2.0 INTERFACE ETN - STIMULATOR, NERVE ETN XOMED MFG JACKSONVILLE 8252410 36671700

    Patients

    Seq Age Sex Outcome Treatment
    1