BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERFACE 8252800 RESPONSE 2.0 INCREMENT

    MDR report key: 3006212 · Received March 6, 2013

    Report

    Report Number
    1045254-2013-00211
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Report Date
    February 16, 2012
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K024316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 SENSOR 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. THIS PRODUCT WAS BEING USED FOR TREATMENT, NOT DIAGNOSIS.

    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 "NOT WORKING/INTERMITTENT." THERE WAS NO SUGGESTION OF PATIENT INJURY OR INVOLVEMENT. TESTING/REPAIR DID NOT CONFIRM THE REPORTED EVENT AS THERE WAS NO FAULT FOUND WITH THE RETURNED DEVICE. THE AVAILABLE INFORMATION INDICATES THE CUSTOMER EXPERIENCED A SUDDEN FAILURE, WHICH 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
    96019 INTERFACE 8252800 RESPONSE 2.0 INCREMENT ETN - STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8252800 46780500

    Patients

    Seq Age Sex Outcome Treatment
    1