BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM EMG ENDOTRACHEAL TUBE

    MDR report key: 3806275 · Received May 12, 2014

    Report

    Report Number
    1045254-2014-00110
    Event Type
    Malfunction
    Date Received
    May 12, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K112686
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT MEDICAL PRODUCTS: NIM 3.0 RESPONSE MAINFRAME, ID#8253001, SERIAL #(B)(4), LOT #205836981, MFR DATE: 04/18/2012. (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. VISUAL ANALYSIS FOUND SAMPLE WITHOUT THE ORIGINAL PRODUCT POUCH OR BOX. A TORN LABEL FROM THE BOX WAS RETURNED WITH THE SAMPLE, IDENTIFYING PART NUMBER AS 8229708, FROM LOT NUMBER 0208101734. THERE WAS CONSIDERABLE AMOUNT OF WHITE COLOR BIO-RESIDUE PRESENT INSIDE THE TUBE NEAR THE CUFF WHICH INDICATED CUSTOMER USE / HANDLING OF THE DEVICE. FROM VISUAL EVALUATION, A MEDICAL TAPE WAS FOUND WRAPPED AROUND THE TUBE AND ELECTRODE ASSEMBLY. NO DAMAGE TO THE ELECTRODE ASSEMBLIES WAS NOTICED. THE ADAPTER ON THE TUBE AT THE PROXIMAL END WAS MISSING AND WAS NOT RETURNED WITH THE SAMPLE. ELECTRICAL EVALUATION: [EQUIPMENT USED: FLUKE MULTIMETER, ASSET# 1153-J, CALIBRATION DUE: (B)(4)] - OBSERVATIONS: WHEN COMPARED TO THE ASSEMBLY DRAWING REVISION E, THE END TO END RESISTANCE OF THE ELECTRODES SHALL BE LESS THAN 200 OHMS AND THE ACTUAL READINGS WERE AS FOLLOWS: RED = 11.2 OHMS, RED WITH STRIPE = 19.2 OHMS, BLUE = 28.5 OHMS, BLUE WITH STRIPE = 17.4 OHMS. THE READINGS WERE FOUND TO BE WITHIN THE DRAWING SPECIFICATION. THERE WERE ALSO NO SHORT CIRCUITS BETWEEN ELECTRODES AND NO INTERMITTENT BEHAVIOR WAS OBSERVED. IT SHOULD BE NOTED THAT UPON REMOVAL OF THE MEDICAL TAPE, SOME MINOR LEVEL OF RESIDUE WAS FOUND ON SILVER TRACES NEAR THE CLAMSHELL BUT DID NOT CAUSE THE ELECTRODE RESISTANCE TO BE OUT OF SPECIFICATION SINCE NONE OF THE SILVER TRACES WERE BROKEN AT ANY POINT. THERE WAS NO EVIDENCE OF IMPROPER MANUFACTURING OR SUPPLIER ISSUE. THE INSTRUCTIONS FOR USE (B)(4) REVISION A WARN AND IDENTIFY MULTIPLE REASONS FOR A REDUCED, IF NOT COMPLETELY ELIMINATED, EMG RESPONSES TO DIRECT OR PASSIVE NEURAL STIMULATION. THE INSTRUCTIONS FOR USE CONTAIN DETAILED INSTRUCTIONS FOR PREPARATION OF THE TUBE, PLACEMENT, AND SET UP. BASED ON THE ANALYSIS FINDINGS THE REPORTED COMPLAINT (NO RESPONSE) COULD NOT BE CONFIRMED AND THERE WAS NO FUNCTIONAL FAULT FOUND WITH THE RETURNED DEVICE. SOME POSSIBLE CONTRIBUTING FACTORS TO THE COMPLAINT EVENT MAY BE RELATED WITH DEVICE SET-UP OR CUSTOMER HANDLING / USER RELATED ISSUES (WHICH INCLUDES PROPER PLACEMENT OF THE DEVICE), BUT COULD NOT BE CONFIRMED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ¿THYROID CASE, USING [A] NIM RESPONSE 3. WE GOT NO RESPONSE TO DIRECT STIMULATION OF THE NERVE. WE DID GET RESPONSES ON THE NON-OPERATIVE SIDE WHEN NOT STIMULATING. WARBLE TONE INDICATING CURRENT WAS BEING DELIVERED WAS HEARD AND WAS SET AT CONTINUOUS. TUBE WAS REPOSITIONED AND POSITIONING RE-CHECKED. CURRENT WAS INCREASED UP TO 2 MA, STILL WITHOUT A RESPONSE. THRESHOLD WAS SET AT 100 MV, AND NO SUB THRESHOLD RAW EMG SOUND WAS PRESENT DURING STIMULATION. AFTER THE SURGERY WHICH OTHERWISE WENT ROUTINELY, THE PATIENT HAD NORMAL VOCAL CORD FUNCTION, AND MY EQUIPMENT HAS CHECKED OUT AS FUNCTIONING NORMALLY, AFTERWARDS WHEN TESTED WITH A PATIENT SIMULATOR. ANESTHESIA SAID THERE WERE NO PARALYTIC AGENTS IN EFFECT DURING THE PERIOD IN QUESTION. I HAVE THE TUBE WE USED, AND WOULD LIKE IT TESTED, AS I HAVE NO EXPLANATION FOR THE LACK OF RESPONSE TO STIMULATION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283952 NIM EMG ENDOTRACHEAL TUBE STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8229708 0208101734

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR