BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERFACE RESPONSE 2.0 INCREMENT

    MDR report key: 3011009 · Received March 14, 2013

    Report

    Report Number
    1045254-2013-00272
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    August 1, 2012
    Report Date
    August 7, 2012
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K024316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING COULD NOT DUPLICATE CUSTOMER'S COMPLAINT. 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 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. 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. THE 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 PATIENT INTERFACE SERVES AS A JUNCTION FOR ELECTRODES AND CABLES BETWEEN THE PATIENT AND THE MAINFRAME, WHICH PRESENTS THE POSSIBLY FOR CONNECTION ISSUES, SOME THAT HAVE THE POTENTIAL TO GO UNDETECTED. THE MAINFRAME ON THE OTHER HAND HAS BUILT IN AUDIO AND VISUAL WARNINGS TO ALERT THE USER OF A SYSTEM FAILURE; THEREFORE, THIS REPORT EVENT WAS MOST LIKELY CAUSED BY THE PATIENT INTERFACE. EVALUATION OF THE MAINFRAME FOUND A DEAD CPU BATTERY, WHICH IS UNLIKELY TO BE A CONTRIBUTING FACTOR TO THE FIELD OBSERVATION. IT SHOULD BE NOTED THAT THERE ARE MANY NON-DEVICE RELATED ISSUES THAT CAN BLOCK A COMPLETED ELECTRICAL CIRCUIT OR INHIBIT A RESPONSE: SUCH AS THE USE OF PARALYTIC ANESTHESIA AGENTS; NON-CONDUCTIVE/DRY TISSUES, OR A NERVE FATIGUED BY OVERSTIMULATION. IN ADDITION, DAMAGE TO THE DEVICE OR MISUSE CAN LEAD TO A DEVICE MALFUNCTION. WHEN SUCH SITUATIONS OCCUR, THE SURGEON CAN FALSELY MISINTERPRET THE INFO AS A NEGATIVE, I.E. THAT A NERVE IS NOT PRESENT WHEN IT REALLY IS PRESENT. 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 MFR 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 "NO STIMULUS IS GOING THROUGH." THERE WAS NO SUGGESTION OF PATIENT INJURY, HOWEVER THE EVENT OCCURRED INTRA-OPERATIVELY. TESTING/REPAIR DID NOT FIND ANY FAULT WITH THE CABLE. THE AVAILABLE INFO 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 INFO IS AVAILABLE AND INVESTIGATION AND/OR PRODUCT ANALYSIS COULD NOT RULE OUT THE POTENTIAL FOR A FALSE NEGATIVE RESPONSE. 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 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
    108216 INTERFACE RESPONSE 2.0 INCREMENT ETN-STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8252800 42916200

    Patients

    Seq Age Sex Outcome Treatment
    1