MAUDE Adverse Event Report: MEDTRONIC DOMINICANA NIM® EMG - ENDOTRACHEAL TUBE - TRIVANTAGE®; STIMULATOR, NERVE

Model Number	8229738
Medical Device Problem Codes	Difficult to Insert (1316); Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 procedure the probe bends too much during the operation, despite the safety measures taken, making it impossible to unbend.The operation had to be stopped 3 times to reposition the probe.There was 20 minutes delay in the procedure. the procedure was completed with the reported product.There was no patient injruy.
Additional Manufacturer Narrative
H3: analysis of the device was completed and found that visually the device was returned in a u-shape state.There was a yellowish residue on the outside diameter of the cuff balloon.Under magnification, there were small voids in the blue ink trace (underneath the adhesive).Due to the wire harness being cut, each wire was stripped to perform continuity testing.Electrically, the resistance from end to end shall be less than 200 ohms, and the actual measurements were 42 ohms (blue), 13 ohms (blue with white stripe), 19 ohms (red), and 20 ohms (red with white stripe) which all electrodes were in specification.Functionally, for further analysis, a syringe was used to inject 15cc of air into the cuff and the cuff inflated and deflated with no issues.The device failed console functional testing due to defective state of the wire harness upon return.In the returned condition, there was no out of specification co ndition that was related to the complaint.H6: codes updated.Previously applied codes fdm b17 and fdr c20 are no longer applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant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 - TRIVANTAGE®
• Common Device Name: STIMULATOR, NERVE
• Manufacturer (Section D): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer (Section G): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer Contact: justin ellis ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635265677
• MDR Report Key: 20769051
• Report Number: 9612501-2024-02979
• Device Sequence Number: 8137314
• Product Code: ETN
• UDI-Device Identifier: 00763000041533
• UDI-Public: 00763000041533
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K112686
• 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): 01/02/2025

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: 8229738
• Device Catalogue Number: 8229738
• Device Lot Number: 0228304306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 11/25/2024
• Supplement Report FDA Received Date: 01/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2024
• 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