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

Model Number	8229707
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis confirmed visually, there was no significant damage to the packaging carton when returned.The carton contained inserts (b)(6) and a zip lock bag with the tube in it.The harness was wrapped in a clear surgical tape.There were traces of biological contamination on the cuff, tip of the tube, and inside the murphy eye.The continuity check was performed and electrically, resistance from end to end shall be less than 200 ohms and the actual measurements were, red (over 200 ohms), red with white stripe (over 200 ohms), blue (over 100 kilo ohms), and blue with white stripe (67.0 ohms), all electrodes out of specification except blue with white stripe electrode.Under the magnification, there were voids present in red and red with white stripe trace pads.Functionally, the device was connected to a nim system for electrode check and functional test (trace pads were submerged in a saline solution and stylet was used for tube manipulation).The electrode check failed for vocalis1 and vocalis2.As for the functional test, there was a noise present on the nim, especially after the tube manipulation, the channel1 was producing a lot of noise (constantly was going above 400¿v).A review of the global complaint data showed one other complaint about this lot number.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 thyroidectomy with nim vital nerve monitoring, a lot of noisy artifacts were present throughout the case on both sides/electrodes.Changed pi boxes, and checked for electrical interference, repositioned the tube, and performed an electrode check.The procedure was extended to 10 minutes.The procedure was completed with the reported products.There was 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: 22477950
• Report Number: 1045254-2025-01728
• Device Sequence Number: 8543931
• Product Code: ETN
• UDI-Device Identifier: 00643169782594
• UDI-Public: (01)00643169782594(17)270416(10)0226389651
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: 0226389651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2023
• 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: 04/17/2023
• 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: 46 YR
• Patient Sex: Unknown