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

Model Number	8229307
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Codes	Unintended Extubation (4564); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the emg tube was used during the operation.The balloon of the monitoring endotracheal tube was found to have air leakage.The doctor replaced the endotracheal tube in time.15-20 ml air was used to inflate the cuff.No intracuff pressure was monitored.Syringe, regular air was used to inflate the cuff.No patient injury.
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa 624392.H3: product analysis found visually, there was no significant damage to the packaging carton.The pouch was open from 3 of 4 sides and taped with a clear tape.Emg tube and electrodes were not secured to the packaging tray.The harness was wrapped in a paper tape.There was a biological contamination on the tip of the emg tube (inside the tip of inflation lumen, near the murphy eye).Electrically, the continuity check was performed and the resistance for each lead shall be between 1.7 ohms and 3.7 ohms.The actual measurements were red 3.1 ohm, red (with clear tube) 3.5 ohms, blue 3.1 ohm, and blue (with clear tube) 3.1 ohm (all measurements within specification).Functionally, used a syringe to inflate 20cc of air into the cuff and the cuff started deflating immediately after it was inflated with 20cc of air.Inflated cuff was submerged under the water and leakage showed at the tip of inflation tube lumen.In the returned condition, there was an 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.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: 21641683
• Report Number: 1045254-2025-00910
• Device Sequence Number: 20726525
• Product Code: ETN
• UDI-Device Identifier: 00643169789531
• UDI-Public: 00643169789531
• 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): 03/19/2025

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: 06/09/2026
• Device Model Number: 8229307
• Device Catalogue Number: 8229307
• Device Lot Number: 0224516015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2022
• Initial Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2022
• 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: Unknown