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	05/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: analysis of the device found visually, the device was returned in a large plastic bag.The plastic bag contained pouch with the tube in it.The pouch was open from 3 of 4 sides, and the open sides of the pouch were closed/stapled when returned.There was no damage noted in the construction of the tube.However, there were traces of voids noted in the trace pads.The continuity check was performed and electrically, resistance from end to end shall be less than 200 ohms and the actual measurements were, red (96.7 ohms), red with white stripe (87.4 ohms), blue (127.3 ohms), and blue with white stripe (77.5 ohms), all electrodes within specification.Functionally, the electrodes were connected to the nim system while tube was submerged in a saline solution.The electrode check passed and as for functional test, the channel 1 was noisy (over 200 v).The tube was manipulated (each electrode trace was bent by using the stylet) and again resulted in passing the electrode check and the functional test channel 1 was noisy.A review of the global complaint data showed no other complaints about this lot number.In the returned condition, there was no out of specification condition that was related to the complaint.This report is being submitted as part of remediation activities associated with capa#: 643143, which is addressing mdr reporting guidance 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 during procedure, after intubating the patient, the electrodes were connected to the interface of the patient, checked but nim 3.0 did not recognize, repositioned the tube various times without success.Tested the equipment with the simulator and it worked normally.Reconnected to tube and remained unresponsive.The surgery was extended by 2 hours.The surgery was completed without monitoring.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: 22478077
• Report Number: 1045254-2025-01732
• Device Sequence Number: 8016348
• Product Code: ETN
• UDI-Device Identifier: 00643169782594
• UDI-Public: (01)00643169782594(17)270124(10)0225877834
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Recall,Notification
• Type of Report: Initial
• Report Date (Section B): 07/11/2025

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: 8229707
• Device Catalogue Number: 8229707
• Device Lot Number: 0225877834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2023
• 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: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2023
• 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