MAUDE Adverse Event Report: MEDTRONIC DOMINICANA 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 Codes	Unintended Extubation (4564); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: analysis of the device found visually, there was no damage in the construction of the device.There were traces of biological contaminants on the outside diameter of the cuff balloon on the distal end of the device.Electrically, resistance from end to end shall be less than 200 ohms and the actual measurements were 27.2 ohms (blue), 10.1 ohms (blue with white stripe), 19.5 ohms (red), and 19.0 ohms (red with white stripe) which all the electrodes were in specification.A stylet was used to manipulate the shape of the device, but no intermittent behavior was observed.Functionally, for further analysis, the device was connected to a nim system, and the device passed the electrode check.Additionally, the device was submerged in a saline solution and there was no erratic behavior/feedback during functional testing.For additional analysis, a syringe was used to inject 15cc of air into the cuff and there were no issues during inflation or deflation.A review of the global complaint data showed no other complaints about this lot number.In the returned condition, there was no out of specification condition that was related to the complaint.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 in the operating room, while attempting to utilize the nim monitor to for nerve stimulation during a thyroidectomy.With two of the three tubes we were unable to maintain a solid signal for vocalis 1 and vocalis 2 channels even upon verification of placement with the glide scope and visualization.Able to successfully maintain signal with the third tube.No known patient impact.

• 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: 22519526
• Report Number: 9612501-2025-01879
• Device Sequence Number: 8827083
• Product Code: ETN
• UDI-Device Identifier: 00763000033965
• UDI-Public: (01)00763000033965(17)261123(10)0225530127
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare 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: 8229708
• Device Catalogue Number: 8229708
• Device Lot Number: 0225530127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2023
• 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: 11/24/2022
• 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 Sex: Unknown