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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2025
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 while using 2-channel subdermal electrodes, the red cable malfunctioned.The electrode was placed subdermally, and although the electrodes were reading "ok," there was no response during testing.Repositioning did not resolve the issue.After replacing the box and using a different cable, everything worked fine.There was no known patient impact.
Additional Manufacturer Narrative
H6: previously applied codes of imdrf annex d: d16, annex e: e2401 and annex f: f24 are no longer applicable.Correction in h6: previously reported code of imdrf annex b: b17 was not incorrect and now it has been updated.Medtronic submits this report to comply with fda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
Additional information received stating that there was no patient impact related to the event.

• 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: 23818832
• Report Number: 9612501-2025-03347
• Device Sequence Number: 9409814
• Product Code: GXZ
• UDI-Device Identifier: 00763000034030
• UDI-Public: (01)00763000034030(17)290801(10)0231957465
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2026

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: 0231957465
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 03/04/2026
• Date Device Manufactured: 08/02/2025
• 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