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

Model Number	8229706
Medical Device Problem Codes	Break (1069); Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that during a thyroid surgery, an emg tube was used during preoperative preparation.It was found that the cuff was leaking.Procedure extended time by 15 minutes. the procedure was completed with backup product(s). there is no patient impact.
Additional Manufacturer Narrative
H3: the device, packaging tray, both electrodes, and an open pouch were returned in a large plastic sleeve (non-original packaging).The pouch was open from 3 of 4 sides when returned.Upon return, traces of contamination were observed at the distal end of the tube.A syringe was used to inject 15cc of air into the cuff, and the cuff was slowly deflating.Furthermore, the cuff was inflated again and submerged in water for leak observation.There was no leakage observed coming from the cuff.Same as the cuff, the inflation assembly was submerged in the water for leak observation, and leakage was observed coming from the pilot balloon, there was a puncture in the pilot balloon.The device failed due to defective condition upon return and the inability to inflate.The complaint was confirmed, due to an out of specification condition.H6: additional information suggest that b17 and c20 longer apply to this 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 a thyroid surgery, an emg tube was used during preoperative preparation.It was found that the cuff was leaking.Procedure extended time by 15 minutes. the procedure was completed with backup product(s). there is no patient impact.
Additional Manufacturer Narrative
H6: additional information suggest that d16 longer apply to this 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.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 DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer (Section G): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer Contact: justin ellis ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635265677
• MDR Report Key: 24031998
• Report Number: 9612501-2026-00067
• Device Sequence Number: 10498705
• Product Code: ETN
• UDI-Device Identifier: 00763000033941
• UDI-Public: (01)00763000033941(17)290719(10)0231744295
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/10/2026

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: 8229706
• Device Catalogue Number: 8229706
• Device Lot Number: 0231744295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 02/03/2026; 03/10/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/26/2026; 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2025
• 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: Female