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

Model Number	8229707
Medical Device Problem Codes	Inappropriate Audible Prompt/Feedback (2280); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: analysis of the device found visually, there was reddish brown colored contamination on the distal end of the device, near the murphy eye, and on the cuff balloon when returned.There was also a white, tacky residue on the outside diameter of the device near the clamp shell.Under magnification, there were small holes in the blue and red with white electrode trace pads.Additionally, portions of the wire harness were cut when returned therefore the electrode wires had to be stripped in order to perform continuity testing.Electrically, for the wire harness, the cable shall exhibit continuity from strip end to the connecting pin with individual resistance to be less than 10 ohms, end to end, and the actual measurements between the stripped end and the protected pin (lead/connector) were all 0.3 ohms for all 4 electrodes which was in specification.From the other stripped end of the wire harness to the trace pads, resistance from end to end shall be less than 200 ohms and the actual measurements had no reading on the distal ends of the pad and resistances greater than 200 ohms on the proximal ends for all 4 electrodes which was out of specification.For further analysis, a stylet was used to manipulate the shape of the device and all electrodes remained out of specification.Functional console testing could not be performed due to the cut wire harness of the device.A review of the global complaint data showed one similar complaint about this lot number.In the returned condition, there was an 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 by the hcp that during intra-op, surgeon was performing a neck dissection with laryngeal nerve monitoring along with surface electrodes in channel 3 and 4.Site called to say nim vital was very loud on channels 1 and 2 (vocalis 1 and 2).Sales rep did an electrode check on the system and no connection from channels 1 and 2.Emg tube was plugged in properly to the patient interface.Channels 3 and 4 worked fine.After case switched the trivantage electrodes to channels 3 and 4 and still received no connection on the emg check.Hooked up the patient interface to the patient simulator and all connections received green check marks.The procedure was completed with the reported product.After extubating the patient, the nurse in the room cut the emg plug in leads from the tube.They are included in the biohazard bag.There was 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: 22478014
• Report Number: 1045254-2025-01731
• Device Sequence Number: 8040871
• Product Code: ETN
• UDI-Device Identifier: 00643169782594
• UDI-Public: (01)00643169782594(17)270301(10)0226102998
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• 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: 0226102998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2023
• 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: 03/02/2023
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 68 KG