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

Model Number	8229706
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Unintended Extubation (4564); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the endotracheal tube was used intraoperatively; the customer reported that no signal could be monitored during the procedure; after replacing it with a new endotracheal tube of the same model, monitoring was possible. the nim system shown as self test was failed in the beginning of the case.The patient conditions and machine settings unchanged when the replacement was used.There was a procedure delay and the procedure was extended to 20 minutes.There was no injury to the patient.
Additional Manufacturer Narrative
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 ; +1(763)526-5677
• MDR Report Key: 50768574
• Report Number: 9612501-2026-02543
• Device Sequence Number: 16092350
• Product Code: ETN
• UDI-Device Identifier: 00763000033941
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 09/15/2026

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 Expiration Date: 07/24/2026
• Device Model Number: 8229706
• Device Catalogue Number: 8229706
• Device Lot Number: 0224401023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2026
• Initial Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 07/25/2022
• 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: Female