BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM CONTACT EMG

    MDR report key: 2020329 · Received March 14, 2011

    Report

    Report Number
    2020329
    Event Type
    Malfunction
    Date Received
    March 14, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 14, 2011
    Manufacturer
    MEDTRONIC XOMED, INC
    Product Code
    BTR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS PERFORMING A LEFT THYROID LOBECTOMY ON PATIENT. PHYSICIAN INSERTED THE NIM ENDOTRACHEAL TUBE PROPERLY BEFORE START OF SURGERY. ALL ELECTRODES WERE PLACED PROPERLY. DURING THE SURGERY, THE RECURRENT LARYNGEAL NERVE WAS IDENTIFIED, BUT WHEN TOUCHED WITH THE NIM PROBE, THE NIM MONITOR DID NOT RECOGNIZE IT. THE SALES REP FROM MEDTRONIC WAS CALLED AND HE WALKED STAFF THROUGH SOME CHECKS. EVERYTHING WAS HOOKED UP CORRECTLY. THE ANESTHESIOLOGIST WAS ALSO ASKED TO MAKE ADJUSTMENTS TO THE ET TUBE WITH NO CHANGE. THE NIM MONITOR STILL DID NOT WORK CORRECTLY.WE HAVE HAD ISSUES WITH THE NIM NOT MONITORING THE NERVE IN THE PAST.======================MANUFACTURER RESPONSE FOR ENDOTRACHEAL TUBE, NIM CONTACT EMG======================MANUFACTURER PROVIDED RGA FOR PRODUCT RETURN EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIM CONTACT EMG EMG ENDOTRACHEAL TUBE BTR MEDTRONIC XOMED, INC * 65668100

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR