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

Model Number	8229706
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Use of Device Problem (1670); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
It was reported that the tube was kinked and had electrodes malfunction during the procedure.The electrodes failed to show proper i mpedances/connection and corrupted the patient data with artifact during use, active monitoring during the total thyroidectomy procedure.The issue was not evident immediately upon attempting to monitor as it occurred randomly throughout the procedure.The device did not show 0 as full stim was sent and received.The electrodes channels were going out.The unit was used for the first time and it did not displayed any error message.The ground and return electrodes were replaced, pod replaced, all connections to base, amplifiers, and stim box checked.There was no delay with the procedure.The procedure was completed without the use of monitoring.There was no patient impact.

• Brand Name: NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: justin ellis ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635265677
• MDR Report Key: 22381042
• Report Number: 1045254-2025-01632
• Device Sequence Number: 13116247
• Product Code: ETN
• UDI-Device Identifier: 00643169782587
• UDI-Public: (01)00643169782587(17)231216(10)0219159323
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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: 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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/16/2023
• Device Model Number: 8229706
• Device Catalogue Number: 8229706
• Device Lot Number: 0219159323
• 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: 12/13/2021
• Initial Report FDA Received Date: 07/02/2025
• Date Device Manufactured: 12/17/2019
• 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