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

Model Number	8227410
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during cochlear implant removal, field contact was requested to come to the or.One channel was on the nim vital was very reactive and registering events (while the patient was not being touched) and the other channel was not.Turned event capture off and the active channel was about 100 uv and other about 7uv.Patient put into deeper sleep.Issue continued on.Switched from vital to 3.0.Same issue persisting.Doctor stated they do not want to change electrodes since patient already draped.Repositioning of patient was not attempted.Electrocautery was used during the procedure.The nim was positioned on the opposite side of the or, in a different outlet.No electrodes laid across the electrocautery wire from what the user could see.Physician assistant andfield rep suspect bad potentially bad electrodes since both vital and 3.0 giving same results.Field rep examined placement of elect rodes and believed them to be positioned well.No noticeable damage to electrodes.Field contact confirmed patient does not have a pacemaker.The procedure was completed with the reported product.There was no patient impact.
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
H6: previously added imdrf annex code b17 is no longer valid medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant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: previously added imdrf annex code d16 is no longer valid.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: 20342330
• Report Number: 9612501-2024-02509
• Device Sequence Number: 15469394
• Product Code: GXZ
• UDI-Device Identifier: 00763000034030
• UDI-Public: 00763000034030
• Combination Product (Y/N): N
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 8227410
• Device Catalogue Number: 8227410
• Device Lot Number: 0229292681
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: 12/05/2024; 01/13/2025
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 12/30/2024; 01/13/2025
• Date Device Manufactured: 07/16/2024
• 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: Male
• Patient Weight: 133 KG