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

Model Number	8229307
Medical Device Problem Codes	Failure to Unfold or Unwrap (1669); Unintended Deflation (4061)
Health Effect - Clinical Code	Unintended Extubation (4564)
Date of Event	06/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: product analysis observed that device, both electrodes, packaging tray, and an open pouch were returned in a large plastic sleeve.The pouch was open from 3 of 4 sides when returned.There were no traces of contamination observed on the device or any other returned components.There was no damage observed in the construction of the returned device.However, when syringe was used to inject 20cc of air into the cuff, the cuff could not inflate.One side of the inflated cuff was uneven; it was stuck to the tube.The device failed due to inability to inflate properly.The complaint was confirmed, due to an out of specification condition.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 during thyroid surgery, uneven cuff inflation of the emg tube was observed during intubation.Although the cuff and tube were checked prior to use and confirmed to be functioning properly, a cuff issue was identified after the emg tube intubated into the patient, and leading to immediate extubation.The 5 ml of air was used to inflate the cuff and 5ml size syringe was used to inflate the endotracheal tube cuff.The procedure was successfully completed with the backup product, resulting in a delay of up to 10 minutes.There was no patient injury.
Additional Manufacturer Narrative
H6: code fdc d1102 has been updated.The previously updated fdc d16 was no longer applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant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: 22960629
• Report Number: 1045254-2025-02090
• Device Sequence Number: 21241666
• Product Code: ETN
• UDI-Device Identifier: 00643169789531
• UDI-Public: (01)00643169789531(17)270430(10)0226478982
• 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,Followup
• Report Date (Section B): 10/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8229307
• Device Catalogue Number: 8229307
• Device Lot Number: 0226478982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2025
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male