BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERFACE 8252800 RESPONSE 2.0 INCREMENT

    MDR report key: 2802481 · Received October 18, 2012

    Report

    Report Number
    1045254-2012-00485
    Event Type
    Malfunction
    Date Received
    October 18, 2012
    Report Date
    September 29, 2011
    Manufacturer
    XOMED MFG JACKSONVILLE
    Product Code
    IKN
    PMA / PMN Number
    K024316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING COULD NOT VERIFY THE REPORTED MALFUNCTION IN EITHER THE MAINFRAME OR THE PT INTERFACE AND DID NOT FIND FAULT WITH EITHER DEVICE. METHOD(S): ACTUAL INVOLVED IN INCIDENT WAS EVALUATION. CONCLUSION(S): DEVICE EVALUATED AND ALLEGED COMPLAINT COULD NOT BE DUPLICATED. WHEN INF SUGGEST 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 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 PERMEANT 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 IS INTERPRET THAT A NERVE IS NOT PRESENT. THE NIM SYSTEM WAS BUILD 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 OF 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 REGARDING THE NERVE INTEGRITY MONITORING (NIM) SYSTEM, PER DISCUSSION WITH OSB. WHEN INFO SUGGESTS THAT THE NIM EQUIPMENT HAD THE POTENTIAL TO NOT STIMULATE TO EFFECT, OR DETECT ELECTROMYOGRAPHY (EMG), THIS RETROSPECTIVE REVIEW (WITHOUT THE BENEFIT OF ADDITIONAL INFO) ASSUMES THAT THE FAILURE WAS DEVICE-RELATED AND MAY HAVE GONE UNDETECTED: THE CUSTOMER RETURNED THE NIM-RESPONSE 2.0 NERVE MONITORING SYSTEM, WHICH INCLUDES THE PT INTERFACE, THE MUTING DETECTOR PROBE AND THE NIM 2.0 MAINFRAME, FOR EVALUATION/REPAIR COMMENTING: "NOT RECOGNIZING THE 'NOTE'". IT IS UNCLEAR WHAT THE CUSTOMER MEANT BY 'NODE' AND THIS TERM COULD BE INTERPRETED AS "NERVE NODE'. THERE WAS NO ALLEGATION OF PATIENT INJURY AND NO PT INFO WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERFACE 8252800 RESPONSE 2.0 INCREMENT ENT-STIMULATOR, NERVE IKN XOMED MFG JACKSONVILLE 8252800 57759100

    Patients

    Seq Age Sex Outcome Treatment
    1