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

Model Number	8227411
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: analysis results were not available as of the date of this report.A follow-up report will be submitted 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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that before use, the electrode was unable to sense.They have tried reconnecting, and still the issue persists.The procedure was completed by reconnecting the probe to the patient interface.There was no patient impact.
Additional Manufacturer Narrative
H3:product analysis found that upon receipt, the packaging carton was damaged and contained an insert; one pouch with green and red/white electrodes; one pouch with blue and red paired electrodes; and one pouch with orange and violet paired electrodes.All pouches were open on two of four sides upon return.No traces of contamination were observed on the returned electrodes.Electrically, the resistance requirement from end to end shall be less than 2 ohms.Measured values were as follows: the green electrode measured 1.1 ohms; the red/white electrode measured 1.0 ohm; the orange paired electrode measured 1.5 ohms and 1.0 ohm; the violet paired electrode measured 1.1 ohms and 1.2 ohms; and the red paired electrode measured 1.9 ohms and 1.9 ohms, all of which were within specification.However, testing of the blue paired electrode revealed a short circuit, as continuity was observed between both poles regardless of measurement points.Furthermore, x ray analysis of the needle housing revealed that the internal poles were touching, confirming the short circuit.The complaint was confirmed, due to an out of specification condition.H6: the previously applied fdm b21 and frd c21 are no longer applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant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 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: 24750930
• Report Number: 9612501-2026-00939
• Device Sequence Number: 10359992
• Product Code: GXZ
• UDI-Device Identifier: 00763000034047
• UDI-Public: (01)00763000034047(17)290625(10)0231624658
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Followup
• Report Date (Section B): 06/11/2026

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: 8227411
• Device Catalogue Number: 8227411
• Device Lot Number: 0231624658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Supplement Date Received by Manufacturer: 04/10/2026; 06/11/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 05/04/2026; 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2025
• 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