BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERFACE RESPONSE 2.0 INCREMENT

    MDR report key: 3011029 · Received March 14, 2013

    Report

    Report Number
    1045254-2013-00271
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    August 20, 2012
    Report Date
    August 20, 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

    UNIT HAD NO STIMULATION RESPONSE DUE TO FUSE FAILURE. 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. THE ECLIPSE PATIENT MODULE SERVES AS AN INTERFACE BETWEEN THE PATIENT AND THE ECLC/CONTROLLER. IT IS DESIGNED TO DELIVER STIMULUS AND RECORD THE READINGS VIA ELECTRODES. WHEN INFO SUGGESTS THAT THE NIM ECLIPSE 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 PATIENT 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 POSSIBILITY 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 REPORTED EVENT WAS MOST LIKELY CAUSED BY THE PATIENT INTERFACE. NO FAULT FOUND DURING ANALYSIS OF MAINFRAME, HOWEVER, THE CPU BATTERY WAS REPLACED. 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 STIMULATION/INTERMITTENT STIMULATION, MONITORS OKAY.¿ THERE WAS NO SUGGESTION OF PATIENT INJURY, HOWEVER, THE EVENT OCCURRED INTRAOPERATIVELY. TESTING/REPAIR FOUND A FAILED FUSE. 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 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
    108129 INTERFACE RESPONSE 2.0 INCREMENT ETN-STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8252800 45502200

    Patients

    Seq Age Sex Outcome Treatment
    1