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	10/06/2025
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 that probe stim didn't work.When attempting to stimulate the nerve, the 'stimulus delivery' tone was heard, but it did not repeat if the surgeon stimulated too rapidly.No waveform was displayed on the monitor during nerve stimulation.No muscle relaxant was used.The procedure was completed with backup probe.There was no patient injury.
Additional Manufacturer Narrative
H3: product analysis stated that the handle and the probe were placed in a resealable bag and returned in a double plastic sleeve (non-original packaging).Upon return, the probe was inserted into a handle.The traces of dark residue were observed on the cable.There was no damage observed on 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 was no reading issue 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: 23415708
• Report Number: 9612501-2025-02833
• Device Sequence Number: 8956705
• Product Code: ETN
• UDI-Device Identifier: 00763000417024
• UDI-Public: (01)00763000417024(17)321020(10)0229908522
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 11/24/2025

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: 0229908522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/22/2024
• 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