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

Model Number	8229707
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	01/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3:product analysis confirmed that visually, the device together with an open pouch was returned in a large plastic bag.The pouch was open from 2 of 4 sides of the pouch.The adapter was missing from the tube and wire harness was not wrapped in tape paper when returned.There was a biological contamination on the cuff and murphy eye.Electrically, the resistance from end to end shall be less than 200 ohms, and the actual measurements were 44.1 ohm (red), 20.2 ohms (red with white stripe), 31.6 ohms (blue), and 38.7 ohms (blue with white stripe), all within specification.Functionally, the device was connected to nim system for electrode check and functional test while tube was submerged in a saline solution.The electrode check passed as soon as connected to the nim as well as functional test.The tube was manipulated (pulled out of saline, reshaped, and submerged in saline again) and tested once more resulting in electrode and functional test passing.For further analysis syringe was used to inject 15cc of air into the cuff.The cuff deflated imme diately.There was a visible puncture noted on the cuff, and puncture measured approximately 0.0440 inches (out of specification).A review of the global complaint data showed no other complaints about this lot number.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 three consecutive 7.0mm trivantage tubes were introduced into the patient's trachea because no electrode check seemed to pass.According to the anesthesiologist, the maximal tube size was used for the patient, and the patient was not under anesthetics at the time of intubation.Also, no lubricant was used on the external walls of the tube.The nim 3.0 neuro was also rebooted multiple times during the procedure, and electrodes re-inserted into the patient interface without it having any impact on the electrode check.The procedure extended for one hour.Thyroidectomy was performed without monitoring, without any patient harm.No patient injury reported.

• 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: 22518229
• Report Number: 1045254-2025-01791
• Device Sequence Number: 12782133
• Product Code: ETN
• UDI-Device Identifier: 00643169782594
• UDI-Public: (01)00643169782594(17)260529(10)0224445553
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 07/16/2025

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: 05/29/2026
• Device Model Number: 8229707
• Device Catalogue Number: 8229707
• Device Lot Number: 0224445553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2022
• 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-0696-2024
• Patient Sequence Number: 1
• Patient Sex: Female