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

Model Number	8229737
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	06/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: analysis of the device found visually, there was no damage or anomalies in the device's construction.The biological contaminants were cleaned off the emg contacts before electrical testing.Electrically, the resistance of the tube electrodes from end to end shall be less than 200 ohms, and the actual measurements were; red 40 ohms, red [w/white band] 120 ohms, blue 59 ohms, and blue [w/white band] 65 ohms.There were no shorts between circuits or intermittent behavior while manipulating the circuits.When viewed under magnification, there were no cracks in the electrode contacts.Note - there were scratches on the electrode contacts, and the red electrode plug was bent however it did not appear to affect the device's function.In the returned condition, there was no out-of-specification condition identified.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 professional (hcp) reported that during a procedure for thyroidectomy, the left and right electrode for the true vocal cords was marked x on the monitor set up, while properly placed, - no check marks, despite changing interface and monitor.The endotracheal tube had to change intraoperatively.The patient did not have any injuries from this problem.The patients nerve was intact postoperatively.The case was interrupted/delayed for about 25 minutes while we were trouble shooting and reintubating/exchanging the endotracheal tube.There was a risk of losing the airway when exchanging the endotracheal tube.There was no known 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: 22381393
• Report Number: 1045254-2025-01638
• Device Sequence Number: 15560973
• Product Code: ETN
• UDI-Device Identifier: 00643169782648
• UDI-Public: (01)00643169782648(17)231014(10)0218692344
• 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: Recall,Notification
• 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: 10/14/2023
• Device Model Number: 8229737
• Device Catalogue Number: 8229737
• Device Lot Number: 0218692344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• 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: 10/15/2019
• 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