MAUDE Adverse Event Report: MEDTRONIC DOMINICANA NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®; STIMULATOR, NERVE

Model Number	8229738
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.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.
Event or Problem Description
It was reported that during total thyroidectomy procedure, the electrode check, everything was green and showed good impedance.During stimulation with the probe, there was muscle contraction, but no nerve sound or biphasic curve was ever detected, although the contraction and the nerve were clearly visible to the naked eye.User changed the tube from the same model and size, it worked without any issues.Anesthesia assumes that the first tube may have been positioned slightly more outward than the one placed subsequently, but in that case, they do not understand why the check showed everything green and cord impedances 0.1.Threshold was 100 and uv and threshold was set to 100.Muscle relaxant was used just in the beginning but then reverted the procedure was completed with backup product(s).There was 20 minutes delay in procedure.There was no patient impact.
Event or Problem Description
It was reported that during total thyroidectomy procedure, the electrode check, everything was green and showed good impedance.During stimulation with the probe, there was muscle contraction, but no nerve sound or biphasic curve was ever detected, although the contraction and the nerve were clearly visible to the naked eye.They switched from the nim vital to the nim 3.0, and the issue persisted.They then changed the tube to the same model and size, after which it worked.Anesthesia assumes that the first tube may have been positioned slightly more outward than the one placed subsequently, but in that case, they do not understand why the check showed everything green and cord impedances 0.1.Threshold was 100 and uv and threshold was set to 100.Muscle relaxant was used just in the beginning but then reverted the procedure was completed with backup product(s).There was 20 minutes delay in procedure.There was no patient impact.
Additional Manufacturer Narrative
H3: product analysis found that the device was returned in a large plastic bag.Upon return, traces of contamination were observed on the cuff and some trace pads, while voids were observed in all four electrode trace pads.No other damage except voids was observed on the tube.Electrically, the resistance from end to end shall be less than 200 ohms; the actual measurements were 28.3 ohms (blue), 11.5 ohms (blue/white), 12.3 ohms (red), and 39.6 ohms (red/white), all of which were within specification.Furthermore, the device was connected to a nim console, and the trace pads were submerged in a saline solution for a functional test.The device passed the electrode check, and no excess noise was recorded during the functional test.All four silver traces were manipulated and bent to a 90° position with no issues.No reading issues were observed during the analysis of the returned device.The complaint was not confirmed, no out of specification condition was observed.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.

• Brand Name: NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer (Section G): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer Contact: justin ellis ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635265677
• MDR Report Key: 24411167
• Report Number: 9612501-2026-00533
• Device Sequence Number: 20318172
• Product Code: ETN
• UDI-Device Identifier: 00763000041533
• UDI-Public: (01)00763000041533(17)280930(10)0229798234
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K112686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8229738
• Device Catalogue Number: 8229738
• Device Lot Number: 0229798234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown