BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®

    MDR report key: 6156463 · Received December 8, 2016

    Report

    Report Number
    1045254-2016-00415
    Event Type
    Malfunction
    Date Received
    December 8, 2016
    Date of Event
    November 10, 2016
    Report Date
    November 14, 2016
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    UDI-DI
    00643169060791
    PMA / PMN Number
    K112686
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4): BALL TIP 1MM PROBE, LOT # 0211194199, MANUFACTURED DATE ¿ APR/28/2016, EXPIRATION DATE ¿ APR/26/2024, 510(K) # K934426, (B)(4). THE PRODUCT WAS RETURNED FOR ANALYSIS. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF EMG TUBE (PRODUCT NUMBER 8229707, LOT NUMBER 0210611979) ONE UN-SEALED SAMPLE, PART NUMBER 8229707, FROM LOT NUMBER 0210611979 WAS RECEIVED. VISUALLY, THERE WAS NO DAMAGE OR ANOMALIES IN THE CONSTRUCTION OF THE DEVICE THAT WOULD HAVE RESULTED IN THE REPORTED EVENT: ¿THE TUBE AND PROBE WERE NOT DETECTING NERVES / NOT RESPONDING.¿ THE RESISTANCE OF THE ELECTRODES FROM END TO END SHALL BE LESS THAN 200 OHMS AND THE ACTUAL MEASUREMENT OF EACH CIRCUIT ARE AS FOLLOWS; RED 22 OHMS, RED [W/WHITE BAND] 19 OHMS, BLUE 25 OHMS, AND BLUE [W/WHITE BAND] 18 OHMS. THERE WERE NO OPEN CIRCUITS AND NO OUT OF SPECIFICATION CONDITION OF THE MAIN TUBE ELECTRODES. THERE WERE NO SHORTS BETWEEN CIRCUITS AND NO INTERMITTENT BEHAVIOR WHILE MANIPULATING THE TUBE AND WIRES. WHEN VIEWED UNDER MAGNIFICATION, THERE WERE NO CRACKS IN THE ELECTRODE CONTACTS. THE ELECTRODE CONTACTS / PADS WERE ALIGNED WITH THE CURVATURE OF THE TUBE AND MIDLINE. PER THE XVI A CONTINUITY TEST IS PERFORMED PRIOR TO FINAL PACKAGING. THE IFU PROVIDES CONTRAINDICATIONS AND WARNINGS THAT IDENTIFY REASONS WHY A USER MAY EXPERIENCE REDUCED OR ELIMINATED EMG RESPONSES TO DIRECT OR PASSIVE NEURAL STIMULATION SUCH AS; PARALYZING AGENTS / LUBRICANTS / SPRAYS, NEUROMUSCULAR FATIGUE FROM PROLONGED OR REPEATED EXPOSURE TO ELECTRICAL STIMULI, DEEP ANESTHESIA, WHICH MAY SUPPRESS NEUROELECTRICAL ACTIVITY, INSUFFICIENT CONTACT BETWEEN THE ELECTRODES AND VOCAL CORDS DUE TO MISPLACEMENT OR USING A TUBE SIZE THAT IS TOO SMALL, AND DISPLACEMENT DURING THE PROCEDURE WHEN ROTATING, FLEXING, OR EXTENDING THE PATIENT¿S HEAD AND NECK. THERE WAS NO FAULT FOUND AND NO EVIDENCE OF IMPROPER MANUFACTURING, THEREFORE MANUFACTURING HAS BEEN RULED OUT AS A LIKELY CAUSE. THERE WAS NO EVIDENCE OF IMPROPER MANUFACTURING AND THEREFORE HAS BEEN RULED OUT AS A LIKELY CAUSE. THE DEVICE CONDITION WAS IN SPECIFICATION / PERFORMED AS EXPECTED, AS IT RELATES TO THE COMPLAINT. ANALYSIS OF BALL TIP PROBE (PRODUCT NUMBER 8225275, LOT NUMBER 0210611979) ONE UN-SEALED SAMPLE, PART NUMBER 8225275, FROM LOT NUMBER 021119419 WAS RECEIVED. THERE WAS NO DAMAGE TO THE PACKAGING TO INDICATE A CAUSE. VISUALLY, THERE WAS NO DAMAGE OR ANOMALIES IN THE CONSTRUCTION OF THE DEVICE THAT WOULD HAVE RESULTED IN THE REPORTED EVENT. THE PROBE WAS INSTALLED INTO A NIM SYSTEM AND FUNCTIONALLY TESTED AT 1.0MA STIMULATING CURRENT WITH A 100UV THRESHOLD; THERE WAS A 1.02 STIMULATION RETURN AND A WAVEFORM / TONE AROUND 200UV INDICATING CURRENT DELIVERY; THE PROBE PERFORMED AS INTENDED. THERE WAS NO FAULT FOUND OR EVIDENCE OF IMPROPER MANUFACTURING THEREFORE HAS BEEN RULED OUT AS A LIKELY CAUSE. THERE WAS NO EVIDENCE OF IMPROPER MANUFACTURING AND THEREFORE HAS BEEN RULED OUT AS A LIKELY CAUSE. THE IFU PROVIDES MULTIPLE REASONS THAT WILL SIGNIFICANTLY REDUCE, IF NOT COMPLETELY ELIMINATE, EMG RESPONSES TO DIRECT OR PASSIVE NERVE STIMULATION AS A RESULT OF USE ERROR. THE DEVICE CONDITION WAS IN SPECIFICATION / PERFORMED AS INTENDED, AS IT RELATES TO THE COMPLAINT. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE SYSTEM DID NOT ALERT THE USER OF THE ISSUE. THERE WERE NO WAVEFORMS OR ALARMS NO MATTER WHERE THE PROBE DETECTED. THE SURGEON DID NOT TRY TO REPOSITION THE EMG TUBE. HE GAVE UP THE TUBE AND COMPLETED THE SURGERY WITHOUT THE NIM SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A THYROIDECTOMY PROCEDURE THE EMG TUBE AND PROBE WERE NOT DETECTING NERVES. THIS PROBLEM WAS NOTICED AT THE BEGINNING OF THE SURGERY. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804925 NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE® STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8229707 0210611979 00643169060791

    Patients

    Seq Age Sex Outcome Treatment
    1