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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure, the electrode check kept x for both channel.User changed to another patient interface, but still x for both channels.There was a procedure delay of 10 minutes.The procedure was completed with the reported product.The patient status is reported as alive with no injury.Additional information received, reported that the electrodes failed immediately after intubating the emg tube.The electrodes were interchanged to channel 3 and 4 but still the issue could not be resolved.
Additional Manufacturer Narrative
H3: analysis found visually, the packaging carton was somewhat damaged when returned.The packaging carton contained an open pouch with a size 6 trivantage tube.There were traces of contamination found at the distal end of the tube.There was a white tape wrapped around the tube near the clamp shell.There were small voids found in a blue electrode trace pad.When returned, the tube was missing harness, it was cut off.The remaining portion of harness (ends) was stripped off for continuity check.Electrically, the resistance from end to end shall be less than 200 ohms, and the actual measurements were red (19.9 ohms), red with white stripe (10.7 ohms), blue (32.2 ohms), and blue with white stripe (11.5 ohms), all within specification.Functional testing was not possible due to the tube damage (harness cut off).Additionally, a syringe was used to inject 15cc of air into the cuff, and the cuff inflated/deflated with no issues.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.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: 21907053
• Report Number: 1045254-2025-01194
• Device Sequence Number: 8713297
• Product Code: ETN
• UDI-Device Identifier: 00643169782587
• UDI-Public: 00643169782587
• 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
• Initial Reporter Occupation: Physician
• Remedial Action: Recall,Notification
• Type of Report: Initial
• Report Date (Section B): 04/25/2025

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: 08/10/2026
• Device Model Number: 8229706
• Device Catalogue Number: 8229706
• Device Lot Number: 0224898854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2022
• 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-0743-2022
• Patient Sequence Number: 1
• Patient Sex: Female