BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 2945217 · Received January 31, 2013

    Report

    Report Number
    1045254-2013-00061
    Event Type
    Malfunction
    Date Received
    January 31, 2013
    Date of Event
    August 31, 2009
    Report Date
    November 27, 2012
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    ETN
    PMA / PMN Number
    K024316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: DEVICE EVALUATED AN ALLEGED FAILURE COULD NOT BE DUPLICATED. THIS PT 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 PT INTERFACE SERVES AS A JUNCTION FOR ELECTRODES AND CABLES BETWEEN THE PT AND THE MAINFRAME, WHICH PRESENTS THE POSSIBILITY FOR CONNECTION ISSUES, SOME THAT HAVE THE POTENTIAL TO GO UNDETECTED. THE MAINFRAME ON THE OTHER HAND WAS BUILT IN AUDIO AND VISUAL WARNINGS TO ALERT THE USER OF A SYSTEM FAILURE; THEREFORE, THIS REPORTED EVENT WAS MOST LIKELY CAUSED BY THE PT INTERFACE. WHEN INFO 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 INFO TO SUGGEST AN EVENT COULD NOT BE INTERPRETED FALSELY - THE REPORT IS INCONCLUSIVE AS TO THE CAUSE OF 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 WAS A PRODUCT PROBLEM. THIS PRODUCT WAS BEING USED FOR TREATMENT, NO 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 MFR HAS CHANGED/IMPROVED THE CRITERIA FOR MAKING MDR DECISIONS. UPON A RETROSPECTIVE REVIEW, THE FOLLOWING EVENT IS NOW BELIEVED TO BE REPORTABLE. A CUSTOMER RETURNED A NIM-RESPONSE 2.0 PT INTERFACE AS PART OF A NIM. SYSTEM STATING THAT "THE SURGEON USED A DRILL DURING THE OPERATION AND HE WAS VERY CLOSE TO THE FACIAL NERVE... HE TOUCHED THE NERVE WITH THE BUR TIP (WHEN DRILL IS NOT WORKING)... AND THERE WAS NO RESPONSE FROM NIM, NO SOUND (ALL AUDIO SETTINGS WERE OK)." THERE WAS NO SUGGESTION OF PT INJURY. TESTING/REPAIR COULD NOT CONFIRM THE REPORTED PROBLEM; THE INTERFACE WAS RECEIVED IN GOOD CONDITION AND PASSED ALL INCOMING FUNCTIONAL TESTS. THIS REPORTED EVENT SUGGESTS A SITUATION WHERE A FALSE NEGATIVE WAS SUSPECTED OR OBSERVED AND SYSTEM SAFE-GUARDS (WARNINGS/ALARMS) MAY NOT HAVE IDENTIFIED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43333 NA ETN - STIMULATOR, NERVE ETN XOMED MFG JACKSONVILLE 8252800 62811800

    Patients

    Seq Age Sex Outcome Treatment
    1