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	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that intraoperatively, they, were doing monitoring with the nim vital device from both sides.Everything was fine on the right side (great response from the lrn and vagus); they then started the other side and obtained one response from the left lrn and eventually lost the signal from that side and never recovered.The troubleshooting performed was first, they checked the monitoring equipment for dysfunction: everything was still properly connected, and electrodes check were all good.Secondly, endotracheal tube malposition and misuse of prolonged muscular analgesics: they obtained a positive high response on the contralateral lrn stimulation.From the anesthesia, the tube was in the median line and with the mark ¿20¿ right on the lower teeth.No local analgesics were used, and no significant secretions were present.At the same time that we got a los on the left side the right side always showed a great response.The doctors told me that this is their third time occurring something like this and without any nerve injury afterword.We also filmed a video from that stimulation (vagus from the left side with no response from nim), they saw the contraction of the surrounding muscles.Surgery was performed normally but without any signal from that side.The surgery was extended for 20 minutes.The procedure was completed with the reported product(s).There was no nerve injury.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
H6: the previously applied fdm b17 and fdc d16 are no longer applicable.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.

• 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: 24330602
• Report Number: 1045254-2026-00209
• Device Sequence Number: 4770901
• Product Code: ETN
• UDI-Device Identifier: 00763000033965
• UDI-Public: (01)00763000033965(17)290519(10)0231380050
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2026

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: 8229708
• Device Catalogue Number: 8229708
• Device Lot Number: 0231380050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 03/27/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 04/01/2026
• Date Device Manufactured: 05/20/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown