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

Model Number	8229737
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	12/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the nim d.7 probe for a total thyroidectomy, the electrode did not work and did not fulfill its role.Hcp chose another similar device of the larger size d.7.5 which worked.There was no patient impact in this event.
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.
Additional Manufacturer Narrative
H3: visually, there was a yellowish, semi-opaque residue on the outside diameter of the cuff balloon upon return.Under magnification, there were small voids and markings/scratches in the trace pads and voids in the ink traces (underneath the adhesive).For further analysis, each electrode wire had to be stripped to perform continuity testing.Electrically, the resistance from end to end shall be less than 200 ohms, and the actual measurements were 21 ohms (blue), 9.7 ohms (blue with white stripe), 23 ohms (red), and 10 ohms (red with white stripe) which all electrodes were in specification.Functionally, the device could not be tested due to the damaged condition upon return and the inability to connect the device to a nim system.In the returned condition, there was an out of specification condition that was related to the complaint(due to physical damage).Previous codes b17, c20 and d16 are no longer applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant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: 21215007
• Report Number: 9612501-2025-00207
• Device Sequence Number: 11642024
• Product Code: ETN
• UDI-Device Identifier: 00763000041526
• UDI-Public: 00763000041526
• 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): 05/07/2025

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: 8229737
• Device Catalogue Number: 8229737
• Device Lot Number: 0229631109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2024
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2024
• 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