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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device had a air leakage from the balloon.The air leakage was not obvious when checked before, and it was found when adjusting the position of the endotracheal tube.The leak evident when trying to inflate the cuff to establish the airway during the intubation process.There was no delay in the procedure and the procedure was completed using backup product.There was no patient impact.
Additional Manufacturer Narrative
H3: product analysis of the device found that visually, portions of the inflation assembly were cut when returned.There was surgical tape wrapped around the proximal end of the device near where the wire harness connects to the tube.Functionally, the cut inflation assembly was manipulated to insert into a syringe in order 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 with no leakages observed.For further analysis, a leak test was performed by submerging the balloon under water and no bubbles (leakage) was noticed.Under magnification, no punctures were identified in the balloon or the inflation lumen.Electrically, for additional analysis, the resistance of each lead shall be between 1.7 and 3.7 ohms and the actual measurements were 3.1 ohms (blue), 3.3 ohms (blue with clear tubing), 3.4 ohms (red), and 3.2 ohms (red with clear tubing) which all the electrodes were in specification.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.
Additional Manufacturer Narrative
Correction in h11: this regulatory report is being submitted due to retrospective review through capa 624392.The reason for submitting the late regulatory report was not provided in the earlier submitted details.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: 21443701
• Report Number: 1045254-2025-00550
• Device Sequence Number: 12703026
• 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,Followup
• Report Date (Section B): 03/20/2025

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: 06/07/2026
• Device Model Number: 8229306
• Device Catalogue Number: 8229306
• Device Lot Number: 0224502945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2022
• 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