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

Model Number	8229507
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2023
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 biological contamination on the cuff balloon on the distal end of the device when returned.Surgical tape was wrapped around the wire harness.Electrically, resistance of each lead shall be between 1.7 and 3.7 ohms and the actual measurements were 3.3 ohms (blue), 3.4 ohms (blue with clear tubing), 3.5 ohms (red), and 3.2 ohms (red with clear tubing) which all electrodes were in specification.For further analysis, a stylette was used to manipulate the shape of the device, especially near around the shrink band on the proximal end of the device, and the electrode resistances remained in specification.Functionally, for additional analysis, the device was connected to a nim system and the exposed distal electrode contacts were submerged in saline to perform an electrode test and functional testing and, while manipulating with a stylette, the device passed the electrode check and had no erratic feedback/noise during functional testing.There was no intermittent behavior during stylette manipulation.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that the endotracheal tube does not recognize vocal on the neuro monitor.The monitor was restarted several times without success.The endotracheal tube was rotated several times without success.There was no patient impact reported.

• 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: 21593922
• Report Number: 1045254-2025-00834
• Device Sequence Number: 8266160
• Product Code: ETN
• UDI-Device Identifier: 00763000882426
• UDI-Public: 00763000882426
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2025

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 Model Number: 8229507
• Device Catalogue Number: 8229507
• Device Lot Number: 0225363494
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2022
• 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