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

Model Number	8229737
Medical Device Problem Code	Inappropriate Audible Prompt/Feedback (2280)
Health Effect - Clinical Codes	Unintended Extubation (4564); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that intra-op, the nim tube was inserted and the system had continuous interference; troubleshooting was done, including movement,<(>,<)> manipulation, and replacement of the tube; a new patient interface; and a nim 3.0 was tried.Interference stopped once the tube was changed.There was no patient injury.
Additional Manufacturer Narrative
H3: product analysis found that traces of contamination were observed on the packaging tray, cuff, and tube.The harness was secured to the tube with a pink ribbon.Voids were observed in all four trace pads.Electrically, end-to-end resistance is specified to be less than 200 ohms.Actual measurements were 12.5 ohms (red), 19.3 ohms (red/white), 12.7 ohms (blue), and 13.2 ohms (blue/white), all within specification.The device was then connected to a nim console, and the trace pads were submerged in a saline solution for functional testing.The device passed the electrode check, and no excess noise was recorded.All four silver traces were manipulated and bent to a 90° position, with no issues observed.No anomalies or functional issues were identified during 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: 24937295
• Report Number: 9612501-2026-01121
• Device Sequence Number: 10667961
• Product Code: ETN
• UDI-Device Identifier: 00763000041526
• UDI-Public: (01)00763000041526(17)290328(10)0230979701
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2026

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: 8229737
• Device Catalogue Number: 8229737
• Device Lot Number: 0230979701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/29/2025
• 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