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

Model Number	8227411
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	07/09/2025
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 during pre-op that the device had connecting the electrode to the patient and the device, it was found that after the electrode was connected to the patient, the device showed that the connection was not successful.Procedure was completed with back-up products.There was no patient involved.
Additional Manufacturer Narrative
H3: two sealed pouches and the violet electrode were returned in a small plastic sleeve (non-original packaging).One of the sealed pouches contained paired subdermal red and blue electrodes, while the other sealed pouch contained subdermal green and red/white electrodes.There was no damage noted in the construction of the violet electrode.However, there were traces of contamination observed on the needles and the electrode housing.Electrically, the resistance (for violet electrode) from end to end shall be less than 2.0 ohms and the actual measurements were 6.1 ohm and no reading between both poles which was out of specification.For further analysis, both sealed pouches were opened, and all electrodes were electrically tested.Electrically, the resistance (for red and blue electrodes) from end to end shall be less than 2.0 ohms and the actual measurements were 1.7 ohms and 1.8 ohms between both poles for red electrode, and 1.4 ohms and 1.7 ohms between both poles for blue electrode, which was in specification.Electrically, the resistance (for green and red/white electrodes) from end to end shall be less than 2.0 ohms and the actual measurements were 1.2 ohms for green and 1.0 ohms for red/white electrode which was in specification.All returned electrodes were in specification except the violet electrode.The complaint was confirmed, due to an out of specification condition.H6: codes updated, previously updated codes 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.
Additional Manufacturer Narrative
H6: d1102 code updated, previously updated d16 code 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: 22696879
• Report Number: 9612501-2025-02093
• Device Sequence Number: 9011563
• Product Code: GXZ
• UDI-Device Identifier: 00763000034047
• UDI-Public: (01)00763000034047(17)270713(10)0226973462
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 10/07/2025

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: 8227411
• Device Catalogue Number: 8227411
• Device Lot Number: 0226973462
• 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: 07/09/2025
• Supplement Date Received by Manufacturer: 08/05/2025; 10/07/2025
• Initial Report FDA Received Date: 08/04/2025
• Supplement Report FDA Received Date: 09/02/2025; 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2023
• 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