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

Model Number	8225275
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that intra op, after connecting the equipment, it was discovered that the probe was not releasing current and had no effect when placed on the nerve.Replacing the probe with a new one resolved the issue.There is no patient impact.There is no patient impact.
Additional Manufacturer Narrative
H3: the handle and the probe were returned in a large plastic sleeve (non-original packaging).Upon return, the probe was inserted into a handle.There were no traces of contamination observed on the returned components.There was also no damage observed in the construction of the probe or the handle.Electrically, the resistance of the entire assembly shall be less than 0.3 ohms, and the actual measurement was 0.29 ohms which was in specification.The device was connected to a nim system using a 1.0ma stimulating current and 100v threshold and while stimulating with a patient simulator, the system consistently returned 1.0ma and a waveform/event tone over 200v.There were no issues observed during the analysis of the returned device.The complaint was not confirmed, no out of specification condition was observed.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: 23836686
• Report Number: 9612501-2025-03387
• Device Sequence Number: 5093185
• Product Code: ETN
• UDI-Device Identifier: 00763000036096
• UDI-Public: (01)00763000036096(17)320521(10)0228954229
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/18/2025

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: 8225275
• Device Catalogue Number: 8225275
• Device Lot Number: 0228954229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• 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: Unknown