BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INTERFACE 8253410 NIM NEURO 3.0

    MDR report key: 2802460 · Received October 18, 2012

    Report

    Report Number
    1045254-2012-00487
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Report Date
    November 14, 2011
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: TESTING CONFIRMED THE REPORTED EVENT AND FOUND THE FUSE WAS BLOWN. THE REPORTED "ELECTRICAL SHORT" WAS NOT CONFIRMED. SERVICE AND REPAIR REPLACED THE PARTS. A BLOWN FUSE IN THE PATIENT INTERFACE HAS THE POTENTIAL TO CONTRIBUTE TO FAILURE TO DETECT 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 A 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 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 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 3.0 NERVE MONITORING SYSTEM PATIENT INTERFACE FOR EVALUATION/REPAIR COMMENTING: "NOT WORKING" INTERMITTENT, THERE IS AN ELECTRICAL SHORT IN STIM 1." NO OTHER INFORMATION WAS PROVIDED. THERE WAS NO ALLEGATION OF PATIENT INJURY. NO ELECTRICAL SHORT WAS FOUND, HOWEVER THE REPORTED EVENT WAS CONFIRMED THROUGH TESTING THAT FOUND THE PATIENT INTERFACE FUSE BLOWN. 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 AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATIENT INTERFACE 8253410 NIM NEURO 3.0 ETN - STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8253410 71611600

    Patients

    Seq Age Sex Outcome Treatment
    1