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

Model Number	8229306
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Unintended Deflation (4061)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis of the device found that visually, there was no significant carton damage.The pouch was opened from 3 sides out of 4.The tray and red/white electrode were missing from the pouch, and only endotracheal tube and green electrode were returned.There was a biological contamination on the tube.Both blue leads (positive and negative) were damaged (bent) near the cuff balloon.Electrically, the resistance of each lead shall be between 1.7 and 3.7 ohms and actual measurements were red 3.5 ohms, red (with clear tube) 3.6 ohms, blue 3.4 ohms and blue (with clear tube) 3.5 ohms which showed all leads being within specification.For further analysis used syringe to inflate/deflate 20cc of air into cuff balloon without any issues.Functionally, there was no intermittent behavior while manipulating connections.In the returned condition, there was an out of specification condition that was related to the complaint (due to physical damage).This regulatory report is being submitted due to retrospective review through capa 624392.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.
Event or Problem Description
It was reported that while trying to intubate the endotracheal tube into the patient, it was found that the cuff leaked air.The packaging was damaged while unboxing the product, and the blue lead was also found damaged.Another emg tube had a lead damage.There was no known patient impact associated with this event.

• 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: 21445110
• Report Number: 1045254-2025-00555
• Device Sequence Number: 12552429
• 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: Other Health Care Professional
• 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: 08/25/2023
• Device Model Number: 8229306
• Device Catalogue Number: 8229306
• Device Lot Number: 0218353877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2019
• 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