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

Model Number	8229707
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate Audible Prompt/Feedback (2280)
Health Effect - Clinical Codes	Unintended Extubation (4564); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis confirmed that visually, the tube and a portion of packaging carton were returned in a large (red) plastic bag.The tube was in u-shape when returned.There were traces of biological contamination on the cuff, murphy eye and the tube.There was an orange tape wrapped around the tube with pieces of hair stuck to it.The continuity check was performed and electrically, the resistance from end to end shall be less than 200 ohms, and the actual measurements were 174.1 ohm (red), 51.0 ohm (red with white stripe), 197.4 ohms (blue) and 40.6 ohms (blue with white stripe), all within specification.Functionally, device was connected to nim system (tube was submerged in a saline solution) for electrode check and functional test.The electrode check for red/red (white stripe) electrodes or orbicularis oris failed.As for the functional test, it resulted in intermittent behavior, it was noisy (vocalis 1 was over 200 v).After the tube manipulation, the electrode check passed, and functional test resulted in being still noisy (running over 100 v).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 one similar 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 total thyroidectomy both electrodes were making noise and then eventually turned off.Electrode check was not passing so patient was re-intubated with a new tube (same lot number).Site could not get the electrode check to pass.Ent rep.Tried repowering the nim vital two different times, repowered the pi box twice, tried the pi box both wired and wireless.Eventually tried hooking up the patient simulator and everything connected and electrode check passed.Procedure was completed without a nerve monitor.Procedure delayed by 5 minutes.No patient injury.Later nim vital was being used in another procedure (thyroidectomy) and the nim monitor and tube were all working properly as intended with no issues.

• 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: 22517680
• Report Number: 1045254-2025-01785
• Device Sequence Number: 18157186
• Product Code: ETN
• UDI-Device Identifier: 00643169782594
• UDI-Public: (01)00643169782594(17)270315(10)0226194910
• 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: Notification,Recall
• Type of Report: Initial
• Report Date (Section B): 07/16/2025

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: 0226194910
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2023
• 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: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2023
• 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: 33 YR
• Patient Sex: Female
• Patient Weight: 68 KG