BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVICE 8252600 NIM-RESPONSE 2.0 PATIENT

    MDR report key: 3000023 · Received March 8, 2013

    Report

    Report Number
    1045254-2013-00238
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    October 29, 2012
    Report Date
    November 19, 2012
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K024316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE FUNCTIONED AS INTENDED. 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 A 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 PT INTERFACE AND CABLE PROVIDE THE MEANS FOR CARRYING ELECTROMYOGRAPHIC ACTIVITY FROM THE PT'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. THIS PRODUCT WAS BEING USED FOR TREATMENT, NO DIAGNOSIS.

    Description of Event or Problem · 1

    THE MFR HAS REFINED THE CRITERIA FOR MAKING MDR DECISIONS. UPON A RETROSPECTIVE REVIEW, THE FOLLOWING EVENT IS NOT BELIEVED TO BE REPORTABLE: A CUSTOMER RETURNED A NIM-PATIENT SIMULATOR STATING, "HAS STOPPED WORKING." THERE WAS NO SUGGESTION OF PT INJURY OR INVOLVEMENT. TESTING/REPAIR COULD NOT CONFIRM THE REPORTED EVENT; THE RETURNED DEVICE FUNCTIONED AS INTENDED. HOWEVER, THE AVAILABLE INFORMATION INDICATES THE DEVICE WAS WORKING BUT THEN STOPPED WORKING, AND THE USER WAS NOT ALERTED BY THE SYSTEM ALARM, WARNING SCREEN OR ERROR MESSAGE. A SUDDEN FAILURE IS NOT CONSISTENTLY ACCOMPANIED BY WARNING/ERROR MESSAGES DURING A PROCEDURE. AT THIS TIME WE ARE UNABLE TO CONFIRM WHETHER THE CUSTOMER RECEIVED ANY ERROR MESSAGES OR ALERTS OF THE FAULT. 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
    98847 DEVICE 8252600 NIM-RESPONSE 2.0 PATIENT ETN - STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8252600 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1