BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVICE 8252200 NIM - RESPONSE 2.0 INTERFAC

    MDR report key: 3000041 · Received March 8, 2013

    Report

    Report Number
    1045254-2013-00236
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Report Date
    June 22, 2012
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K024316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING/REPAIR CONFIRMED CONNECTOR FOR THE CABLE WAS CUT OFF. 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 IS 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 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, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    THE MFR HAS REFINED 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 STATING, "IT WAS RUNNING INTERMITTENT; CUT THE CORD THINKING WE COULD SEND A REPLACEMENT CORD." THERE WAS NO SUGGESTION OF PT INJURY OR INVOLVEMENT. TESTING/REPAIR CONFIRMED CONNECTOR FOR THE CABLE WAS CUT OFF AND THERE WAS NO WAY TO RECREATE THE REPORTED EVENT OF RUNNING INTERMITTENTLY. THE AVAILABLE INFORMATION INDICATES THE DEVICE WAS INTERMITTENT, AND THE USER WAS NOT ALERTED BY A SYSTEM ALARM, WARNING SCREEN OR ERROR MESSAGE. INTERMITTENT RESPONSE COULD POTENTIALLY RESULT IN FALSE NEGATIVES. FALSE NEGATIVES COULD POTENTIALLY CAUSE INJURY TO THE PT BY FAILING TO IDENTIFY A REPORTED NERVE. THIS COULD RESULT IN THE SURGEON DAMAGING THE NERVE. AT THIS TIME WE ARE UNABLE TO CONFIRM WHETHER THE CUSTOMER RECEIVED ANY ERROR MESSAGES OR ALERTS. MEDTRONIC WILL ASSUME THAT THE USER DID OT RECEIVED A SYSTEM ALARM, WARNING SCREE OR ERROR MESSAGE, UNTIL IT IS CONFIRMED THAT THEY DID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98890 DEVICE 8252200 NIM - RESPONSE 2.0 INTERFAC ETN - STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8252200 39681100

    Patients

    Seq Age Sex Outcome Treatment
    1