MAUDE Adverse Event Report: MEDTRONIC DOMINICANA NIM® PROBE; STIMULATOR, NERVE

Model Number	8225101
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that intra op, when performing left superficial parotidectomy, when surgeon want to stimulate, no return current and signal at the monitor.They suspected the fuse was blown and replaced new fuse but still no return current.It was suspected that the probe was faulty and opened new probe.Now return current was present.They performed connectivity test to the probe cable and found out the wire cable did not have connectivity.They suspected the wire cable was faulty.There was a delay of 20 minutes.The procedure was completed using backup products.There was no patient impact.
Additional Manufacturer Narrative
This regulatory report is being submitted due to retrospective review through capa 624392.H3: product analysis found visually; the product was returned in the pouch taped from 3 of 4 sides.There were no signs of residue or biological contamination on the product.The probe tip was bent at the distal end of protected pin overmold (gray area on the probe) and proximal end of the tin-plated brass.Electrically, the resistance of the entire assembly shall be less than 0.3 ohms and the actual continuity check resistance measured 0 ohms (out of specification).Functionally, the probe tip securely fitted into handle.The test was performed using nim console and resulted in no reading.The test was repeated with reference probe and resulted in no reading.In the returned condition, there was an out of specification condition that was related to the complaint.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® PROBE
• Common Device Name: STIMULATOR, NERVE
• 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: 21536883
• Report Number: 9612501-2025-00671
• Device Sequence Number: 20743946
• Product Code: ETN
• UDI-Device Identifier: 00763000417024
• UDI-Public: 00763000417024
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K934426
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/06/2025

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: 8225101
• Device Catalogue Number: 8225101
• Device Lot Number: 0224373239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2022
• 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 Age: 71 YR
• Patient Sex: Male
• Patient Weight: 68 KG