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

Model Number	8229738
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate Audible Prompt/Feedback (2280)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis confirmed that the trivantage nim was noisier than expected.The electrode wires in the returned sample were tested for continuity to manufacturing specifications.Electrode wire 1 of 4 ¿ continuity in specification.Electrode wire 2 of 4 ¿ continuity in specification.Electrode wire 3 of 4 ¿ continuity in specification.Electrode wire 4 of 4 ¿ continuity in specification.This report is being submitted as part of remediation activities associated with capa # 643143, which is addressing mdr reporting gu idance from fdas 1995 preamble, which ensures complaints related to corrections and recalls which were previously reported to fda under 21 cfr 806 are now reported as mdrs; this is not a new malfunction/event.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
A healthcare provider (hcp) reported that during parathyroid exploration the trivantage nim was noisier than typical.Both channels were shown to be noisy, orange artifact waveform was present, free run emg at approx 60uv.Reboot of system completed.Electrode check showed that the red channel was a red "x".Swapped blue and red electrodes in patient interface box, red 'x' swapped to the blue channel.Suspected damage to the red electrodes.Surgeon completed the procedure not monitoring the right side.Suggestion made to reintubate or rotate the tube for functional electrodes to be in contact with operative side.There was a 15 minute delay.On follow up, surgeon completed the procedure not monitoring the right side.The red ¿x¿ indicating the electrode not functioning indicated there was something wrong with the red electrodes.There was no reported visible damage, the red ¿x¿ indicating the electrode was not functioning indicated there was something wrong with the red electrodes.The anesthetist indicated to the clinical nurse lead that some torsion had been applied when positioning the tube.The nerve was not visible, no use of the stim probe at the time of the event.

• 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: 22381808
• Report Number: 9612501-2025-01665
• Device Sequence Number: 21228185
• Product Code: ETN
• UDI-Device Identifier: 00763000041533
• UDI-Public: (01)00763000041533(17)240408(10)0219861141
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Remedial Action: Notification,Recall
• Type of Report: Initial
• Report Date (Section B): 07/02/2025

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 Expiration Date: 04/08/2024
• Device Model Number: 8229738
• Device Catalogue Number: 8229738
• Device Lot Number: 0219861141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0743-2022
• Patient Sequence Number: 1
• Patient Sex: Unknown