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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2022
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.The packaging pouch and tray were not re turned, and the wire harness was still wrapped in tape paper.A syringe was used to inject 20-cc of air into the cuff balloon and there were no issues during inflation or deflation.The balloon was re-inflated and deflated multiple times and no leaks were observed.For further analysis, a leak test was performed by submerging the balloon and inflation assembly, at separate times, under water and not bubbles (leakage) was noticed.Electrically, for additional analysis, the resistance of each lead shall be between 1.7 and 3.7 ohms and the actual measurements were 3.7 ohms (blue), 3.5 ohms (blue with clear tubing), 3.4 ohms (red), and 3.6 ohms (red with clear tubing) which all the electrodes were in 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.
Event or Problem Description
It was reported that before surgery, the endotracheal tube has an air leak and the probe tip was found to be flat which was supposed to be spherical.No patient injury.

• 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: 21371601
• Report Number: 1045254-2025-00457
• Device Sequence Number: 8624502
• 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): 02/13/2025

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: 04/25/2026
• Device Model Number: 8229307
• Device Catalogue Number: 8229307
• Device Lot Number: 0224224776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2022
• 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