BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERFACE 8252800 RESPONSE 2.0 INCREMENT

    MDR report key: 2798741 · Received October 16, 2012

    Report

    Report Number
    1045254-2012-00455
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Date of Event
    August 9, 2011
    Report Date
    August 9, 2011
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K024316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: ANALYSIS OF LABELING PERFORMED. ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED. 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 LEVERS 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 FOUND THE FOLLOWING EVENT: A CUSTOMER RETURNED A NIM-RESPONSE 2.0 PATIENT INTERFACE STATING THAT THERE WAS "NO STIMULATION RESPONSE." THIS REPORTED EVENT WAS VERIFIED BY SERVICE WITH A STIMULATION CONTROL PRINTED WIRE ASSEMBLY (PWA) FAILURE, WHICH WAS IDENTIFIED AS THE CAUSE OF NO STIMULATION RESPONSE. 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. IF A USER EXPERIENCES NO STIMULATION RESPONSE AND DOES NOT RECOGNIZE AN ALARM, THE POSSIBILITY ARISES FOR A SITUATION WHERE A FALSE NEGATIVE CAN OCCUR. THERE WAS NO ALLEGATION OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERFACE 8252800 RESPONSE 2.0 INCREMENT STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8252800 57543900

    Patients

    Seq Age Sex Outcome Treatment
    1