BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERFACE 8252800 RESPONSE 2.0 INCREMENT

    MDR report key: 2982807 · Received February 25, 2013

    Report

    Report Number
    1045254-2013-00150
    Event Type
    Malfunction
    Date Received
    February 25, 2013
    Report Date
    November 27, 2012
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K024316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING/REPAIR FOUND A SHORT IN THE PT INTERFACE CABLE. 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 SEROUS 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 IS BEING USED FOR TREATMENT, NOT 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 NOW BELIEVED TO BE REPORTABLE: A CUSTOMER RETURNED AN NIM-PT INTERFACE 2.0 STATING "HIGH NOISE ON CHANNEL 1." THERE WAS NO SUGGESTION OF PT INJURY OR INVOLVEMENT. TESTING/REPAIR CONFIRMED THE REPORTED EVENT, AND FOUND A SHORT CIRCUIT. A SHORT CIRCUIT IN THE PT INTERFACE, WHICH CAN GO UNDETECTED, HAS BEEN KNOWN TO AFFECT THE DELIVERY OF STIMULUS CURRENT AND HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO PT INJURY (LOSS OF STIMULATION DURING USE LEADING TO A FALSE NEGATIVE). 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
    79289 INTERFACE 8252800 RESPONSE 2.0 INCREMENT ETN MEDTRONIC XOMED, INC. 8252800 53235800

    Patients

    Seq Age Sex Outcome Treatment
    1