BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIM® EMG

    MDR report key: 20298317 · Received September 25, 2024

    Report

    Report Number
    1045254-2024-01592
    Event Type
    Malfunction
    Date Received
    September 25, 2024
    Date of Event
    July 25, 2024
    Report Date
    September 25, 2024
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OYA KALE, FILIZ AKASLAN, GÜLSEN KESKIN AND GÖKHAN TOPTAS. "FREQUENCY OF SIDE EFFECTS EXPERIENCED IN TWO DIFFERENT NIM-EMG TUBES USED IN THYROID AND PARATHYROID SURGERY; A PROSPECTIVE OBSERVATIONAL STUDY", BMC ANESTHESIOLOGY, 2024, 24:253, HTTPS://DOI.ORG/10.1186/S12871-024-02643-1 THIS MDR IS BEING SUBMITTED FOR THE LOSS OF STIMULATION RESPONSE, IRREGULAR EMG RESPONSE, EMG CABLE ERROR, ELECTRODE ERROR CAUSED BY THE EMG TUBES. SECTION E: THE LITERATURE ARTICLE HAS TWO FACILITIES LISTED WHERE THE STUDY WAS PERFORMED. ONE FACILITY IS "DISKAPI YILDIRIM BEYAZIT TRAINING AND RESEARCH HOSPITAL" AND THE OTHER IS "ETLIK CITY HOSPITAL". MEDICAL SAFETY ASSESSMENT HAS BEEN COMPLETED. THE RESULTS REPORTED IN THE ARTICLE DO NOT EXPLAIN WHETHER A MALFUNCTION LED TO THE HARMS LISTED, OR IF ANY HARMS OR PATIENT IMPACT WERE ASSOCIATED WITH THE REPORTED MALFUNCTIONS. THE AUTHORS DO STATE THAT ONE OF THE VENTILATION DISORDERS/HERNIATED CUFF EVENTS RESULTED IN BRONCHOSPASM, WHICH RESULTED IN IMMEDIATE REPLACEMENT OF THE EMG TUBE. BOTH HAZARDOUS SITUATIONS ARE KNOWN AND LABELED PER PRA D00847575, AND IFU M040175C001DOC1 C. TRANSIENT PARALYSIS OF THE VOCAL CORDS (0.8%) CORRELATES WITH THE REPORT OF ¿HOARSENESS AFTER SURGERY¿. WHETHER THE PARALYSIS WAS PERMANENT OR NOT WAS NOT SPECIFIED, AND CAUSE OR CONTRIBUTORY FACTOR CANNOT BE EVALUATED DUE TO INCOMPLETE INFORMATION. VOCAL CORD PARALYSIS IS A KNOWN INHERENT RISK OF THYROID PROCEDURES AND IS ALSO CAPTURED IN THE RISK DOCUMENTATION, PRA D00847575, AND IFU M988679A001 A. THE REPORT OF AIRWAY TRAUMA CANNOT BE CONFIRMED TO BE A RESULTING HARM DUE TO THE USE OF AN EMG TUBE; HOWEVER, THE HARM IS A KNOWN INHERENT RISK FOR ANYONE BEING VENTILATED UNDER GENERAL ANESTHESIA WITH THE USE OF AN ENDOTRACHEAL TUBE, AND IS ALSO KNOWN AND LABELED IN PRA D00847575, AND IFU M040175C001DOC1 C. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE ARTICLE WAS REVIEWED REGARDING THE PROSPECTIVE OBSERVATIONAL STUDY. AMERICAN SOCIETY OF ANESTHESIOLOGISTS (ASA) II-IV 240 CASES, 239 PATIENTS FROM THE ASA II-III GROUP AND 1 PATIENT FROM THE ASA IV GROUP, WHO HAD A BMI > 45 AND USED NIM EMG TUBES FOR THYROID AND PARATHYROID SURGERY, WERE INCLUDED IN THE STUDY. THE AVERAGE AGE OF THE PATIENTS IS 49.50 ± 13.44 YEARS, THE AVERAGE BMI IS 28.25 ± 4.91 KG/M2, THE MEDIAN SURGERY TIME IS 115 (32¿475) MINUTES, 75.7% ARE WOMEN, 97.5% ARE ASA II. MEDTRONIC EMG TUBES WERE USED IN 142 PATIENTS. MEDTRONIC DEVICE AND TUBE WERE USED IN 59.4% OF CASES. IT WAS DETERMINED THAT 74.5% OF THEM USED TUBE 7.0. DESATURATION CONTINUED AFTER INTUBATION WITH A BOUGIE IN A PATIENT WITH A HISTORY OF UPPER RESPIRATORY TRACT INFECTION 1 MONTH AGO. THE MOST COMMON COMPLICATIONS RELATED TO THE TUBE AND THE PATIENTS WERE LOSS OF STIMULATION RESPONSE (14), IRREGULAR EMG RESPONSE (8), CUFF DEFLATION MALFUNCTION (1), VENTILATION FAILURE (5), BRONCHOSPASM(2) AND TRANSIENT PARALYSIS OF THE VOCAL CORDS (1). OTHER COMPLICATIONS ARE AIRWAY TRAUMA(1), EMG CABLE ERROR(1), ELECTRODE ERROR(1). 0.8% OF PATIENTS WITH TRANSIENT RLN PARALYSIS WERE OBSERVED IN THYROID AND PARATHYROID SURGERIES PERFORMED USING NIM-EMG TUBES, 3 PATIENT ALREADY HAD NERVE INVOLVEMENT IN THE PREOPERATIVE PERIOD. REINTUBATION WAS REQUIRED IN 2 PATIENTS(0.8%) DUE TO VENTILATION FAILURE. TRANSIENT RLN PARALYSIS WAS OBSERVED IN 2 PATIENTS WITH SIGNAL LOSS, AND THERE WAS NO PERMANENT PARALYSIS. IN 3 PATIENTS WITH A DIAGNOSIS OF MALIGNANCY, UNILATERAL RLN INVASION, WHICH WASALREADY KNOWN PREOPERATIVELY, WAS SEEN BOTH INTRAOPERATIVELY AND CONFIRMED BY IONM DEVICE. REINTUBATION WAS PERFORMED IN THE 36TH AND 83RD MINUTES CASES, CONSIDERING THAT THE CAUSE OF VENTILATION FAILURE AND BRONCHOSPASM WAS CUFF HERNIATION. WHEN THE REMOVED TUBE WAS EXAMINED, IT WAS OBSERVED THAT THE CUFF STRETCHED AND LENGTHENED. SINCE PATIENT SAFETY WAS AT THE FOREFRONT AT THE TIME OF THE INCIDENT AND DID NOT KNOW THE EXACT REASON, DEEMED IT APPROPRIATE TO REPLACE THE TUBE AS SOON AS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1198673 NIM® EMG STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. XOM UNK EMG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown