BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM-NEURO 2.0 INTERFACE

    MDR report key: 3012917 · Received March 1, 2013

    Report

    Report Number
    1045254-2013-00179
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Report Date
    November 27, 2012
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K024316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION FOUND BROKEN SOLDER PIN CONNECTIONS ON THE INTERFACE BOARD. THE NIM SYSTEM IS INTENDED FOR USE TO MONITOR SENSORY AND MOTOR PATHWAYS. IF THE SYSTEM FAILS TO PERFORM AS INTENDED, (ESPECIALLY TO EFFECT OR DETECT ELECTROMYOGRAPHIC (EMG) ACTIVITY) IT PRESENTS THE POTENTIAL FOR TEMPORARY OR PERMANENT DAMAGE TO THE NERVE THAT IS PRESENT. 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. 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. THE PATIENT INTERFACE AND CABLE PROVIDE THE MEANS FOR CARRYING ELECTROMYOGRAPHIC ACTIVITY FROM THE PATIENT'S INNERVATED MUSCLES TO THE CONSOLE, AN INTERFACE FOR CARRYING STIMULATION SIGNALS FROM THE CONSOLE TO THE STIMULATING PROBES/ELECTRODES, AND AN INTERFACE TO THE CONSOLE FROM THE INCREMENTING PROBE. THE PATIENT INTERFACE HAS FOUR OR EIGHT COLOR CODED PAIRS OF PATIENT ELECTRODE JACKS, A PATIENT ELECTRODE GROUND JACK, ONE STIMULUS RETURN JACK, TWO STIMULUS OUTPUT JACKS (CONFIGURED TO ACCEPT MONOPOLAR OR BIPOLAR STIMULATING PROBES), AND ONE INCREMENTING PROBE JACK. 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, (ESPECIALLY TO EFFECT OR DETECT ELECTROMYOGRAPHIC (EMG) ACTIVITY) IT PRESENTS THE POTENTIAL FOR TEMPORARY OR PERMANENT DAMAGE TO THE NERVE THAT IS PRESENT.

    Description of Event or Problem · 1

    THE MANUFACTURER HAS REFINED THE CRITERIA FOR MAKING MDR DECISIONS. UPON A RETROSPECTIVE REVIEW, THE FOLLOWING EVENT IS NOW BELIEVED TO BE REPORTABLE: A CUSTOMER RETURNED A NIM-PATIENT INTERFACE 2.0 STATING "CONTACT FAILURE." THERE WAS NO SUGGESTION OF PATIENT INJURY, HOWEVER THE EVENT OCCURRED INTRA-OPERATIVELY. TESTING/REPAIR FOUND LOOSE ELECTRODE JACKS. THE AVAILABLE INFORMATION INDICATES THAT THE DEVICE WAS NOT WORKING PROPERLY, WHICH COULD SUGGEST AN ISSUE WITH THE POTENTIAL TO CAUSE INJURY TO THE PATIENT BY FAILING TO IDENTIFY A NERVE AND RESULTANT DAMAGE BY THE SURGEON. NO FURTHER INFORMATION IS AVAILABLE AND INVESTIGATION AND/OR PRODUCT ANALYSIS COULD NOT RULE OUT THE POTENTIAL FOR A FALSE NEGATIVE RESPONSE. THE NIMH 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90340 NIM-NEURO 2.0 INTERFACE ETN - STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8252410 52476200

    Patients

    Seq Age Sex Outcome Treatment
    1