BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM® EMG

    MDR report key: 24797159 · Received April 7, 2026

    Report

    Report Number
    1045254-2026-00477
    Event Type
    Injury
    Date Received
    April 7, 2026
    Date of Event
    June 14, 2021
    Report Date
    April 7, 2026
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TSUNG-JUNG LIANG, NAI-YU WANG, SHIUH-INN LIU AND I-SHU CHEN. "VOCAL CORD GRANULOMA AFTER TRANSORAL THYROIDECTOMY USING ORAL ENDOTRACHEAL INTUBATION: TWO CASE REPORTS". LIANG ET AL. BMC ANESTHESIOLOGY, 21:170, 2021. DOI: 10.1186/S12871-021-01393-8 MEDICAL SAFETY ASSESSMENT HAS BEEN COMPLETED. THE HARM(S) OF GRANULOMA FORMATION FOLLOWING INTUBATION WERE CONTRIBUTED TO BY THE PLACEMENT OF THE EMG TUBES; HOWEVER, GRANULOMA FORMATION IS A KNOWN, INHERENT RISK FOLLOWING INTUBATION WITH ANY TYPE OF ENDOTRACHEAL TUBE. GRANULOMAS TYPICALLY FORM 2 ¿ 10 WEEKS AFTER INTUBATION AND ARE PREDOMINANTLY FOUND IN WOMEN 1. 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 VOCAL CORD GRANULOMA AFTER TRANSORAL THYROIDECTOMY USING ORAL ENDOTRACHEAL INTUBATION: TWO CASE REPORTS. 6.0MM AND 7.0MM ENDOTRACHEAL TUBES WERE USED IN TWO PATIENTS. FIRST PATIENT WITH A 5-YEAR HISTORY OF GRAVES¿ DISEASE PRESENTED WITH A 2.6-CM LEFT THYROID NODULE DURING HER REGULAR FOLLOW-UP. FINE-NEEDLE ASPIRATION CYTOLOGIC EXAMINATION SUGGESTED THE NODULE WAS A PAPILLARY CARCINOMA. SHE HAD NO KNOWN HISTORY OF GASTROESOPHAGEAL REFLUX DISEASE OR OTHER SYSTEMIC DISEASES, AND HER JOB DID NOT REQUIRE EXCESS VOICE USAGE. SHE UNDERWENT TRANSORAL ENDOSCOPIC TOTAL THYROIDECTOMY WITH CENTRAL NECK LYMPH NODE DISSECTION. GENERAL ANESTHESIA WITH ORAL INTUBATION WAS PERFORMED USING AN EMG TUBE (INTERNAL DIAMETER = 6.0 MM) FOR INTRAOPERATIVE NEUROMONITORING (IONM). THE ENDOTRACHEAL TUBE WAS FIXED AT THE MOUTH ANGLE. TRANSORAL ENDOSCOPIC THYROIDECTOMY WAS PERFORMED ACCORDING TO THE PROCEDURE. DURING THE SURGERY, BOTH THE RECURRENT LARYNGEAL NERVES WERE IDENTIFIED VISUALLY, AND THEIR FUNCTION WAS CONFIRMED VIA IONM. THE PATIENT¿S POSTOPERATIVE COURSE WAS UNEVENTFUL EXCEPT FOR OCCURRENCE OF TRANSIENT HYPOPARATHYROIDISM, WHICH RESOLVED 1 WEEK LATER. HER VOICE WAS FINE WITHOUT ANY HOARSENESS, AND SHE WAS DISCHARGED ON POSTOPERATIVE DAY 4. THE FINAL PATHOLOGIC EXAMINATION CONFIRMED THE DIAGNOSIS OF PAPILLARY CARCINOMA WITH LYMPH NODE METASTASIS. HER CONDITION WAS UNREMARKABLE DURING THE POSTOPERATIVE OUTPATIENT FOLLOW-UPS AT 1 WEEK AND 1 MONTH. HOWEVER, SHE DEVELOPED HOARSENESS, FORCED VOICE, AND VOICE FATIGUE TWO MONTHS AFTER THE SURGERY. STROBOLARYNGOSCOPY REVEALED SYMMETRICAL AND MOVABLE VOCAL CORDS BUT ALSO SHOWED A GRANULOMA OVER THE LEFT VOCAL PROCESS. SHE WAS PRESCRIBED ORAL PREDNISOLONE AND A PROTON PUMP INHIBITOR ALONG WITH VOICE THERAPY. HER SYMPTOMS IMPROVED THEREAFTER, AND THE GRANULOMA APPEARED TO HAVE SHRUNK SIGNIFICANTLY AS SEEN ON THE 1-MONTH FOLLOW-UP STROBOLARYNGOSCOPY. SECOND PATIENT PRESENTED WITH A 3.3-CM RIGHT THYROID NODULE WITH ACCOMPANYING MILD COMPRESSION SYMPTOM. FINE-NEEDLE ASPIRATION CYTOLOGIC EXAMINATIONS WERE PERFORMED TWO TIMES, BUT BOTH FAILED TO REVEAL A DIAGNOSIS. SHE UNDERWENT TRANSORAL ENDOSCOPIC RIGHT THYROIDECTOMY UNDER GENERAL ANESTHESIA WITH ORAL ENDOTRACHEAL INTUBATION (TUBE INTERNAL DIAMETER = 7.0 MM). IONM WAS ALSO IMPLEMENTED AND SHOWED A POSITIVE SIGNAL FROM THE RECURRENT LARYNGEAL NERVE. AFTER THE SURGERY, THE PATIENT REGAINED AN INTACT VOICE AND SHOWED A SMOOTH RECOVERY. SHE WAS DISCHARGEDON POSTOPERATIVE DAY 3. AT THE 1- WEEK FOLLOW-UP, HER CONDITION REMAINED UNREMARKABLE, BUT A PATHOLOGIC EXAMINATION REVEALED NODULAR GOITER. NEVERTHELESS, 2 MONTHS AFTER THE SURGERY, THE PATIENT STARTED NOTICING HOARSENESS WITH VOICE FATIGUE. STROBOLARYNGOSCOPY REVEALED A CONTACT GRANULOMA OVER THE POSTEROMEDIAL ASPECT OF THE LEFT VOCAL CORD. SHE DENIED ANY VOICE ABUSE AND HAD NO HISTORY OF GASTROESOPHAGEAL REFLUX DISEASE. ALTHOUGH SHE WAS RECOMMENDED CONSERVATIVE TREATMENT WITH MEDICATION, SHE OPTED FOR GRANULOMA EXCIS ION. HER SYMPTOMS IMPROVED AFTER THE SURGERY. PRIOR TO SURGERY, THEY ROUTINELY PERFORMED VIDEOLARYNGOSCOPY TO CHECK IF THE ELECTRODE ON THE EMG TUBE WAS APPROPRIATELY IN CONTACT WITH THE VOCAL CORD AFTER THE PATIENT WAS INTUBATED AND PLACED IN THE NECK EXTENSION P OSITION. IN BOTH THE PRESENT CASES, THE PATIENTS SHOWED NO LESIONS ON THEIR VOCAL CORD DURING THIS LARYNGOSCOPIC INSPECTION. MOREOVER, THEY HAD NO HISTORY OF GASTROESOPHAGEAL REFLUX DISEASE, AND THEIR JOBS DID NOT REQUIRE EXCESSIVE VOICE USAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858771 NIM® EMG STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. XOM UNK EMG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention