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

Model Number	8227410
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 - evaluation of the returned device was not completed at the time of this report.A follow up report will be sent when analysis is complete.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 pre op surgeon have mentioned the electrode not functioning after connected to patients interface.No readings after tapping the skin simultaneously, they open another electrode to proceed with the surgery.There was no patient impact.
Additional Manufacturer Narrative
H3: there were 4 electrodes (red/white, green, red paired electrode and blue paired electrode) returned in a triple resealable bag.Upon return, there were no traces of biological contamination observed on the electrodes.There was no damage noted in the construction of the returned electrodes.When returned, all electrodes¿ needles were exposed and not protected with white foam/sponge.Electrically, the resistance from end to end shall be 2 ohms, and measurements were: red/white electrode 1.5 ohms, green electrode 1.0 ohms, blue paired electrode 1.7 ohms and 1.9 ohms, and red paired electrode 1.7 ohms and 45 ohms.All electrodes had resistance within specification except red paired electrode that had higher resistance than 2 ohms.In the returned condition, although there was an out of specification condition found during the analysis, there was no out of specification condition found that was related to the complaint as the increase in resistance is most likely attributable to post-manufacturing factors such as clinical use, handling, or environmental exposure and this reading would not cause a skin tap test with no response.The complaint was not confirmed due to no out of specification condition observed related to the complaint.H6: codes are updated.Previously applied fdm b21, fdr c21, fdc d16 codes 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 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: 23904057
• Report Number: 9612501-2025-03489
• Device Sequence Number: 12661527
• Product Code: GXZ
• UDI-Device Identifier: 00763000034030
• UDI-Public: (01)00763000034030(17)270607(10)0226739963
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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,Followup
• Report Date (Section B): 02/09/2026

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: 0226739963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 12/28/2025
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2023
• 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
• Patient Sex: Unknown