BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INTERFACE 8253200 RESPONSE 3.0

    MDR report key: 2802479 · Received October 18, 2012

    Report

    Report Number
    1045254-2012-00490
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Report Date
    October 12, 2011
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHODS: ANALYSIS OF LABELING PERFORMED, ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. 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, WHICH PRESENTS THE POSSIBILITY FOR CONNECTION ISSUES, SOME THAT HAVE THE POTENTIAL TO GO UNDETECTED. THE MAINFRAME ON THE OTHER HAND HAS BUILT IN AUDIO AND VISUAL WARNINGS TO ALERT THE USER OF A SYSTEM FAILURE; THEREFORE, THIS REPORTED EVENT WAS MOST LIKELY CAUSED BY THE PATIENT INTERFACE. 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. 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 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 DETECT 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 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 MONITORING (NIM) SYSTEM, PER DISCUSSION WITH OSB. WHEN INFORMATION SUGGESTS THAT THE NIM EQUIPMENT HAD THE POTENTIAL TO NOT STIMULATE TO AFFECT, OR DETECT ELECTROMYOGRAPHY (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 3.0 PATIENT INTERFACE AS PART OF A NIM SYSTEM, REPORTING THAT IT WAS "WORKING INTERMITTENT WHEN USING STIMULATION/TOUCHING TISSUE DOES NOTHING." THIS EVENT WAS NOT VERIFIED BY SERVICE, AND THE STIMULATING PROBE WAS NOT RETURNED FOR EVALUATION. BASED ON THIS INFORMATION, IT CANNOT BE RULED OUT THAT A NERVE THAT WAS PRESENT WAS NOT BEING STIMULATED AND/OR READ, AND SYSTEM SAFE-GUARDS (WARNINGS/ALARMS) MAY NOT HAVE IDENTIFIED THE ISSUE. IF THIS SITUATION WERE TO RECUR, THE POTENTIAL FOR A FALSE NEGATIVE IS ASSUMED TO EXIST. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATIENT INTERFACE 8253200 RESPONSE 3.0 STIMULATOR, NERVE ETN XOMED MFG JACKSONVILLE 8253200 68216300

    Patients

    Seq Age Sex Outcome Treatment
    1