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

Model Number	8229706
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Unintended Extubation (4564); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: the were 4 devices returned.There was residue consistent with biological contaminates on the device.The electrode wires in the returned samples were tested for continuity to manufacturing specifications.Three of the devices had continuity in specification and one of the device had no continuity unless pressure is applied to the area where the wires attach to the tube.In the returned condition, there was no physical damage observed and there was no out of specification condition identified.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
A distributor reported via manufacturer representative that during a thyroidectomy surgery, when the doctor inserted the tube into the patient's body, the doctor found that the electrode check on the right was always crossed.The doctor tried to adjust the depth of the endotracheal tube and rotate the endotracheal tube, but it was useless.Finally, the doctor replaced a new endotracheal tube to complete the operation.The current stim return shows not 0.It was also mentioned that the electrode check on the right side cannot be detected, so nim shows a cross.The user indicates that the intermittent issue was a connection issue.There was no planned/intervention performed.There was 10 minutes delay in the surgical procedure.The procedure was completed with backup product(s).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: 22382403
• Report Number: 1045254-2025-01645
• Device Sequence Number: 9417951
• Product Code: ETN
• UDI-Device Identifier: 00643169782587
• UDI-Public: (01)00643169782587(17)240406(10)0219861934
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall,Notification
• Type of Report: Initial
• Report Date (Section B): 07/02/2025

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 Expiration Date: 04/06/2024
• Device Model Number: 8229706
• Device Catalogue Number: 8229706
• Device Lot Number: 0219861934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2020
• 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-0743-2022
• Patient Sequence Number: 1
• Patient Sex: Unknown