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

Model Number	8229737
Medical Device Problem Code	Sensing Intermittently (1558)
Health Effect - Clinical Codes	Unintended Extubation (4564); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis confirmed that there was residue consistent with biological contaminates on the device.The electrode wires in the returned sample were tested for continuity.Electrode wire 1 of 4 ¿ continuity in specification.Electrode wire 2 of 4 ¿ continuity in specification.Electrode wire 3 of 4 ¿ continuity in specification.Electrode wire 4 of 4 ¿ continuity in specification.This report is being submitted as part of remediation activities associated with capa # 643143, which is addressing mdr reporting guidance from fdas 1995 preamble, which ensures complaints related to corrections and recalls which were previously reported to fda under 21 cfr 806 are now reported as mdrs; this is not a new malfunction/event.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
A health care provider (hcp) reported via manufacturer representative that during a thyroid surgery.Normal preparation.Normal intubation.Surgeon identified and stimulated the recurrent nerve with the nerve monitoring device.There was no signal on the neuromonitor.The emg tube was re-oriented while stimulation continued, but still no signal curve.Upon request of the surgeon, the patient was extubated and another tube of the same type was used for intubation.Upon stimulation of the nerve with the new tube, emg response signal curves were seen on the neuromonitor and the surgery could be continued normally.There was an approximate of 30 minutes delay for re-positioning and - as this did not improve the situation - extubation.Then re-intubation with another tube of same type there was no patient impact there after.

• 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: 22382970
• Report Number: 9612501-2025-01676
• Device Sequence Number: 8700212
• Product Code: ETN
• UDI-Device Identifier: 00763000041526
• UDI-Public: (01)00763000041526(17)240624(10)0220230426
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Remedial Action: Recall,Notification
• Type of Report: Initial
• Report Date (Section B): 07/02/2025

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 Expiration Date: 06/24/2024
• Device Model Number: 8229737
• Device Catalogue Number: 8229737
• Device Lot Number: 0220230426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0743-2022
• Patient Sequence Number: 1
• Patient Sex: Unknown