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

Model Number	8229706
Medical Device Problem Codes	Obstruction of Flow (2423); Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: product analysis confirmed that the device was returned in a resealable bag.Upon receipt, traces of contamination were observed on the cuff and tip of the tube.A foreign object (white piece of plastic) was secured to the tube with clear tape that had strands of hair adhered to it.The harness had been cut off, and the adapter from the proximal end of the tube was missing.A syringe was used to inject 15 cc of air into the cuff, and no air leak was observed coming from the cuff.The cuff was submerged in water for leak observation; however, no leakage was observed from the cuff.The inflation assembly was then submerged in water for leak observation, and leakage was observed originating from the valve.H6: previous code b17, d16, c20 are no longer valid.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant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 the procedure, changes in airway pressure were observed, suggesting a possible air leak from the emg tube.The tube was replaced, and the surgery was continued.Postoperatively, user submerged the removed tube in water for testing and identified an air leak at the cuff inflation port.The procedure was completed with backup product.The procedure was extended for 15 minutes.There was no patient injury.Additional information received, prior to intubation, testing was performed, and inflation and deflation were normal.

• 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: 25687983
• Report Number: 9612501-2026-01790
• Device Sequence Number: 19994525
• Product Code: ETN
• UDI-Device Identifier: 00763000033941
• UDI-Public: (01)00763000033941(17)290921(10)0232262867
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8229706
• Device Catalogue Number: 8229706
• Device Lot Number: 0232262867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 25 YR
• Patient Sex: Female