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

Model Number	8229307
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis of the device found that visually, the device was returned in a large zip lock bag.The tube had traces of contamination noted inside the proximal end of the tube, on the cuff and middle of the tube.There were surgical tape and clear plastic wrapped around the tube when returned.There was a presence of liquid found inside the adapter.The continuity check was performed and electrically, the resistance of each lead shall be between 1.7 ohms and 3.7 ohms and actual measurements were, red (3.4 ohms), red with clear tube (3.3 ohms), blue (3.4 ohms), and blue with clear tube (3.5 ohms), all electrodes within specification.Functionally, a syringe was used to inject 20cc of air into the cuff, and cuff inflated/deflated with no issues.There were no signs of leakage.For further analysis inflated cuff and pilot balloon were submerged (at separate times) under the water for leakage observation and still there was no leakage found.The device was connected to the nim system and both, electrode check, and functional test passed.There were no issues found.In the returned condition, there was no out of specification condition that was related to the comp laint.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.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 no emg signal was detected during the operation, there is no improper operation, and there was no muscle relaxation throughout the operation.After the endotracheal tube was pulled out, cuff leakage was found.There was no wave form displayed on the monitor when attempting to stimulate the nerve.Postoperative laryngoscopy found that the vocal cord movement was normal and the recurrent laryngeal nerve was not damaged.The procedure was completed without using the device.There was no patient impact.

• 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: 21443913
• Report Number: 1045254-2025-00551
• Device Sequence Number: 17971932
• 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): 02/24/2025

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: 09/25/2026
• Device Model Number: 8229307
• Device Catalogue Number: 8229307
• Device Lot Number: 0225151071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2023
• Initial Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2022
• 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