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	04/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that , during the thyroidectomy procedure with monitoring of the recurrent laryngeal n., during the intubation and placement of the monitoring tube, there are technical failures in the verification of the electrodes, where one of the vowels is not recognized, the tube is re-arranged, possible failures in the surgical field are reviewed, such as electrical interference and it continues to show failures at the time of checking the electrodes without obtaining a positive response.The tube is removed and a new electromyography tube is placed with a reference.Different and different batch to solve the problem presented.The event was resolved by replacing it with another homologous device and being able to proceed with the scheduled procedure.The trivantage endotracheal tube showed the failures when checking the electrodes just at the time of intubation of the patient before starting the procedure and it shows that there is no contact between one of the electrodes with the vocal cord, for which all pertinent measures are taken to correct the failure but no positive response is obtained to the event that occurred, for which the device is removed and replaced by another.The event resulted in surgical delay of 15 minutes.There was no patient injury.
Additional Manufacturer Narrative
H3: analysis of the device found visually, the pouch was open from 3 of 4 sides of the pouch when returned.There was no damage noted in the construction of the device.There were no traces of contamination, scratches, or bubbles.The silver pads and traces were clean and free of any damages.The continuity check was performed and electrically, the resistance from end to end shall be less than 200 ohms, and the actual measurements were red (37.5 ohms), red with white stripe (43.8 ohms), blue (31.9 ohms), and blue with white stripe (38.2 ohms), all within specification.Functionally, the device was connected to the nim system (while tube was submerged in a saline solution) for electrode check and functional test.The electrode check as well as functional test passed as soon as connected to the nim system.There was no noise or intermittent behavior recorded.The electrode check and functional test were repeated after the tube manipulation (tube was manipulated by being pulled out of a saline solution, reshaped, and placed back in a saline solution), no change in result (same as previous testing).For further analysis, a syringe was used to inject 15cc of air into the cuff, and cuff inflated/deflated with no issues.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.

• 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: 22477768
• Report Number: 1045254-2025-01724
• Device Sequence Number: 20818936
• Product Code: ETN
• UDI-Device Identifier: 00643169782594
• UDI-Public: (01)00643169782594(17)270201(10)0225929260
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K112686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 07/11/2025

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: 0225929260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2023
• 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: 02/02/2023
• 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 Age: 27 YR
• Patient Sex: Female