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

Model Number	8229708
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	03/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3:product analysis confirmed that there was no damage to the packaging.Visually, there was no damage in the device's construction that would have resulted in the reported event.Electrically, the resistance of the tube electrodes from end to end shall be less than 200 ohms, and the actual measurements were; red 23 ohms, red [w/white band] 16 ohms, blue 19 ohms, and blue [w/white band] 19 ohms.There were no shorts between circuits or intermittent behavior while manipulating the circuits.When viewed under magnification, there were no cracks in the electrode contacts.A review of the global complaint data showed no other complaints about this lot number.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 by a health care professional that a patient had a presumptive diagnosis of cervical carcinoma for which a thyroidectomy was suggested, the endotracheal tube # 8 was used.At the time of placing the tube, the patient presents a mandibular retrocnatia, proceeded to intubation, the tube does not capture the red cord (right).The tube was removed until the electrodes are captured.At the time of performing the surgery, proceed to stimulate and in the part of the right cords there are no stimulation records.The left part is stimulated and it is verified that there was a response.There was no patient impact.The procedure was completed with the reported product(s) with no delay.

• 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: 22383114
• Report Number: 1045254-2025-01649
• Device Sequence Number: 20608159
• Product Code: ETN
• UDI-Device Identifier: 00643169782600
• UDI-Public: (01)00643169782600(17)230915(10)0218497235
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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
• 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: 09/15/2023
• Device Model Number: 8229708
• Device Catalogue Number: 8229708
• Device Lot Number: 0218497235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• 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: 09/16/2019
• 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 Age: 60 YR
• Patient Sex: Male