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

Model Number	8229306
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Codes	Unintended Extubation (4564); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that customer was performing thyroid surgery and routinely performed preoperative examinations for patient and the i ntubation was normal.After intubation, the cuff was found to leak and could not be used normally.The leak was evident when trying to inflate the cuff to establish the airway during the intubation process.In order to not affect the surgery, replaced with another cannula to ensure the smooth progress of the operation.The leak was not discovered by the user prior to intubating the patient.There was no delay in the surgical procedure.There was no patient or staff impact.
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa: 624392.H3: product analysis found visually, there were no defects in the construction of the device that would have resulted in the reported event.Functionally, a syringe was used to inject 20-cc of air into the cuff balloon and there were no issues during inflation or deflation.Leak tests were performed on the cuff and inflation assembly by submerging both parts under water at separate times and no leaks were observed.The leak test was performed multiple times and no issues occurred.Electrically, for further analysis, resistance of each lead should be between 1.7 and 3.7 ohms and the actual measurements were as follows: 3.4 ohms (blue), 3.6 ohms (blue with clear tubing), 3.4 ohms (red), and 3.3 ohms (red with clear tubing), in which all electrodes were within specification.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
• 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: 21442947
• Report Number: 1045254-2025-00535
• Device Sequence Number: 17972040
• 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): 02/24/2025

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: 09/16/2024
• Device Model Number: 8229306
• Device Catalogue Number: 8229306
• Device Lot Number: 0220789521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2020
• 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