BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERFACE 8250200 NIM-RESPONSE PATIENT

    MDR report key: 2815323 · Received October 26, 2012

    Report

    Report Number
    1045254-2012-00591
    Event Type
    Malfunction
    Date Received
    October 26, 2012
    Report Date
    October 4, 2011
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    ETN
    PMA / PMN Number
    K982595
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: ANALYSIS OF LABELING PERFORMED, VISUAL EXAMINATION, ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. RESULT: SHORT CIRCUIT. CONCLUSION: DEVICE REPAIRED AND RETURNED. WHEN INFORMATION SUGGESTS THAT THE NIM EQUIPMENT HAD THE POTENTIAL TO NOT STIMULATE OF 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 LOCATION 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 MAY 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. A RETROSPECTIVE REVIEW FOND THE FOLLOWING EVENT; A CUSTOMER RETURNED A NIM-RESPONSE PATIENT INTERFACE, ALONG WITH A MAINFRAME, STATING THAT "THE NIM RESPONSE MAINFRAME DOESN'T WORK." SERVICE AND REPAIR FOUND A SHORT IN THE PATIENT INTERFACE CABLE WHICH COULD HAVE BEEN RESPONSIBLE FOR THE REPORT OF THE MAINFRAME NOT WORKING. IN THE ABSENCE OF AN AUDITORY OR VISUAL ARTIFACT, SHORTS IN THE PATIENT INTERFACE, WHICH CAN GO UNDETECTED, HAVE THE POTENTIAL TO CAUSE A FAILURE OF STIMULATION OF AFFECT EMG AS WELL AS A FAILURE TO DETECT EMG. NO FURTHER INFORMATION IS AVAILABLE AND THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERFACE 8250200 NIM-RESPONSE PATIENT ETN - STIMULATOR, NERVE ETN XOMED MFG JACKSONVILLE 8250200 33441100

    Patients

    Seq Age Sex Outcome Treatment
    1