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	06/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis confirmed that visually, there was yellow brownish colored residue on the outside diameter of the cuff balloon on the distal end of the device when returned and surgical tape wrapped near the clamp shell on the proximal end.Additionally, the tube adapter on the proximal end of the device was dislodged from the assembly and not returned.Under magnification, there were small holes/cracks in the blue, red, and blue with white stripe trace pads on the distal end of the device and gray markings/scratches on the red with white stripe trace pad.Electrically, resistance from end to end shall be less than 200 ohms and the actual measurements were 38.8 ohms (blue), 120.4 ohms (blue with white stripe), 96.9 ohms (red), and 68.8 ohms (red with white stripe) which all electrodes were in specification.For further analysis, a stylet was used to manipulate the shape of the device, especially the clamp shell, and the continuity readings remained the same, in specification.Functionally, for additional analysis, the device was connected to a nim system, and the trace pads were submerged in saline to perform an electrode check and functional testing (with the use of a stylet to manipulate the shape of the device at the clamp shell), and the device passed the electrode check and there was no e xcessive feedback/noise during functional testing.There was no intermittent or erratic behavior while manipulating the device with a stylet.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 during thyroid procedure, the blue electrode/channel on the nim vital system was going crazy.User refused to use a bite block with the tube.Technician instructed, electrode check and that same blue channel would only intermittently pass the electrode check (red, green, red).User refused to try adding the bite block then they could just mute that channel and still receive a positive emg response when stimulating on the left/blue through the red channel as long its above 100 threshold.The procedure was completed with the reported product.There was no patient consequences 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: 22478084
• Report Number: 1045254-2025-01733
• Device Sequence Number: 8668434
• Product Code: ETN
• UDI-Device Identifier: 00643169782594
• UDI-Public: (01)00643169782594(17)270425(10)0226455033
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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: 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: 0226455033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2023
• 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: 04/26/2023
• 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: 40 YR
• Patient Sex: Female