BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM® EMG - ENDOTRACHEAL TUBE

    MDR report key: 17826387 · Received September 27, 2023

    Report

    Report Number
    1045254-2023-00753
    Event Type
    Injury
    Date Received
    September 27, 2023
    Date of Event
    July 20, 2023
    Report Date
    September 27, 2023
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    UDI-DI
    00643169789524
    PMA / PMN Number
    K925640
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THYROID SURGERY AFTER INDUCTION OF GENERAL ANESTHESIA, ENDOTRACHEAL INTUBATION BY VIDEOLARYNGOSCOPE (NERVE MONITORING ENDOTRACHEAL TUBE). BREATH SOUNDS IN BOTH LUNGS WERE CLEAR AND SYMMETRICAL, AND THE MONITORING SHOWED THE CARBON DIOXIDE WAVEFORM. AFTER INDUCTION, THE DEPTH OF ANESTHESIA WAS APPROPRIATE, SEVOFLURANE 0.7MAC , REMIFENTANIL 0.18 G/KG/MIN, PROPOFOL 2 MG/KG/H, NOREPINEPHRINE 0.04 G/KG/MIN TO MAINTAIN BLOOD PRESSURE. ABOUT HALF AN HOUR AFTER INTUBATION, THAT WAS, DURING THE PROCESS OF EXPOSING THE THYROID GLAND BY PLACING THE "HEAD HYPEREXTENDED SUPINE POSITION", THE PATIENT WAS SUDDENLY DEVELOPED ANESTHESIA VENTILATOR AND MANUAL VENTILATION UNABLE TO PROVIDE OXYGEN. THE CHEST DID NOT RISE AND FALL SIGNIFICANTLY, THE OXYGEN SATURATION DECREASED PROGRESSIVELY, THE AIRWAY RESISTANCE WAS EXTREMELY HIGH, AND THE BREATH SOUNDS OF BOTH LUNGS WERE WEAK ON AUSCULTATION; THEN THE POSITION PAD WAS REMOVED, PURE OXYGEN WAS INHALED, AND EPINEPHRINE WAS 0.5 MG, METHYLPREDNISOLONE 80MG, AND ROCURONIUM BROMIDE 40MG, THE EFFECT DID NOT IMPROVE SIGNIFICANTLY, AND THE BREATH SOUNDS OF BOTH LUNGS WERE WEAK. THEN THE NERVE MONITORING ENDOTRACHEAL TUBE WAS REMOVED, VENTILATED WITH A FACE MASK, AND THE OXYGEN SATURATION GRADUALLY INCREASED, AND THE WHEEZING SOUND OF BOTH LUNGS WAS OBVIOUS. AFTER THE STABLE CIRCULATION WAS MAINTAINED BY VASOACTIVE DRUGS, THE SURGEON COMMUNICATED WITH THE PATIENT'S FAMILY ME MBER THAT THE OPERATION WOULD BE POSTPONED AND SENT THE PATIENT TO THE ICU FOR OBSERVATION AND TREATMENT. AFTER THE PATIENT WAS FULLY AWAKE, THE ENDOTRACHEAL CATHETER WAS REMOVED. THERE WAS IMPAIRMENT OF RESPIRATORY FUNCTION. IT WAS FURTHER REPORTED THERE WAS NO INABILITY TO INFLATE PRIOR TO HEAD HYPEREXTENSION AND THE REASON FOR THE ROUGH SURFACE IN THIS CASE MENTIONED WAS THAT THE ANESTHESIOLOGY CUSTOMER BELIEVED THAT COMPARED WITH TRADITIONAL ENDOTRACHEAL TUBE, THE MEDTRONIC PRODUCT HAD MORE LEADS. IT WAS SUSPECTED THAT THE DESIGN CAUSED GREATER IRRITATION TO THE TRACHEA THAN A SIMPLE ENDOTRACHEAL TUBE. THE PROBLEM WAS NOT DISCOVERED BEFORE INTUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984008 NIM® EMG - ENDOTRACHEAL TUBE STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8229306 0225942177 00643169789524

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Life Threatening