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

Model Number	8229306
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	01/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa 624392.H3: product analysis found visually, there was no damage in the construction of the device.There was a portion of a tube wrapped around the wire harness and portions of the packaging carton were cut off.In addition, the packaging pouch was not returned with the product.Electrically, resistance of each lead shall be between 1.7 and 3.7 ohms and the actual measurements were 3.2 ohms (blue), 3.3 ohms (blue with clear tubing), 3.4 ohms (red), and 3.3 ohms (red with clear tubing) which all electrodes were in specification.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 to perform a functional test and there was no erratic behavior in either channel.While performing the electrode check and functional test, there was no intermittent behavior while manipulating the shape of the device with a stylet.For additional analysis, a syringe was used to inject 20cc of air into the cuff balloon and there were no issues during inflation or deflation.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.
Event or Problem Description
It was reported that after intubation, no signal could be detected, nor could it be detected after adjusting the position of the endotracheal tube.The intubation position was repeatedly adjusted until the vagus nerve was exposed, and there was no signal in the detection.Threshold set to 100.There was return current.Patient¿s nerve integrity checked prior to closing the site and it was normal.The ¿stimulus delivery¿ tone heard when attempting to stimulate the nerve.No waveform displayed on the monitor when attempting to stimulate the nerve.Drug cisatracurium was given before operation, and there was no addition in the middle.It could be detected signal after the hospital changing the endotracheal tube.There was surgical delay of 30 minutes.There was no patient impact.

• Brand Name: NIM® EMG - ENDOTRACHEAL TUBE
• 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: 21546569
• Report Number: 1045254-2025-00764
• Device Sequence Number: 15187061
• Product Code: ETN
• UDI-Device Identifier: 00643169789524
• UDI-Public: 00643169789524
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K925640
• 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
• Type of Report: Initial
• Report Date (Section B): 03/07/2025

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: 06/05/2026
• Device Model Number: 8229306
• Device Catalogue Number: 8229306
• Device Lot Number: 0224472463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Female