MAUDE Adverse Event Report: MEDTRONIC DOMINICANA NIM® EMG ELECTRODE; ELECTRODE, NEEDLE

Model Number	8227410
Medical Device Problem Codes	False Negative Result (1225); Inappropriate Audible Prompt/Feedback (2280)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during parotid procedure when stimulating the nerve with 0.8, there was only a brief tone.Surgeon could see the nerve twitching when stimulating, got the tone for no nerve, and did not see an emg on the screen.Definitely the nerve that got stimulated.While preforming a tap test the device did what it was supposed to do and also showing an emg and doing the right noise.While working with the probe, there was no emg shown on the display and just the brief tone.There was delay of 45 minutes.The threshold was set down to 20.Still no change.Procedure was completed with competitor nerve monitoring system.There was no patient injury.
Additional Manufacturer Narrative
H3: analysis found visually, there was no damage in the construction of the devices.Electrically, the resistance end to end of the paired electrodes shall be less than 2.0 ohms and the actual measurements were 1.5 ohms for both electrodes (blue) and 1.2 and 1.3 ohms between both electrodes (red) which both devices were in specification.The resistance of the subdermal electrodes end to end shall be less than 2.0 ohms and the actual measurements were 1.0 ohms for both the red/white stim and green ground electrodes which both devices were in specification.In the returned condition, there was no out of specification condition that was related to the complaint.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 ELECTRODE
• Common Device Name: ELECTRODE, NEEDLE
• 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: 21923812
• Report Number: 9612501-2025-01163
• Device Sequence Number: 4059590
• Product Code: GXZ
• UDI-Device Identifier: 00763000034030
• UDI-Public: 00763000034030
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K002992
• 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
• Report Date (Section B): 04/29/2025

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: 8227410
• Device Catalogue Number: 8227410
• Device Lot Number: 0229572963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2024
• 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