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

Model Number	8225101
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	08/17/2025
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 during procedure, probe failed to discharge.The procedure was completed with backup product and there was no patient injury.
Additional Manufacturer Narrative
H3: product analysis found that the probe, handle, insert, and an open pouch were returned in a resealable bag.The pouch was open from 3 of 4 sides when returned.There was no damage or contamination observed on the returned probe or the handle.Upon return, the probe was attached to 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 100 v threshold and while stimulating with a patient simulator, the system consistently returned 1.0ma and a waveform/event tone over 200 v.There were no reading issues observed during the analysis of the returned device.The complaint was not confirmed; no out of specification condition was observed.H6: fdm b17, fdr c20 and fdc d16 codes no longer apply.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: 23013381
• Report Number: 9612501-2025-02404
• Device Sequence Number: 9512043
• Product Code: ETN
• UDI-Device Identifier: 00763000417024
• UDI-Public: (01)00763000417024(17)320504(10)0228826438
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 10/14/2025

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: 0228826438
• 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: 08/17/2025
• Supplement Date Received by Manufacturer: 09/19/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2024
• 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