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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: analysis of the sample was completed, a piece of packaging carton with the label on it and the device were returned in a (triple) resealable bag.There were traces of contamination observed on the cuff and inside the tube.There was also a white tape wrapped around the tube near the clamp shell.A portion of a white tape had traces of light brown residue.There was no damage noted in the construction of the device.However, there were voids observed in all four trace pads.The continuity check was performed and electrically, the resistance from end to end shall be less than 200 ohms and the actual measurements were 15.4 ohms (blue), 22.6 ohms (blue with white stripe), 15.3 ohms (red), and 21.7 ohms (red with white stripe) which all electrodes were in specification.Functionally, the device was connected to a nim system, and the trace pads were submerged in a saline solution for functional test.The device passed the electrode check and there was no excess noise recorded during the functional test.All 4 silver traces were manipulated and bent to the 90° position.There were no issues 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.
Event or Problem Description
It was reported that pre op, the emg tube impedance check could not be cleared.There was no patient involvement.

• 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: 23082113
• Report Number: 9612501-2025-02461
• Device Sequence Number: 4965778
• Product Code: ETN
• UDI-Device Identifier: 00763000033941
• UDI-Public: (01)00763000033941(17)290227(10)0230652553
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 09/18/2025

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: 8229706
• Device Catalogue Number: 8229706
• Device Lot Number: 0230652553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 09/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2025
• 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