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

Model Number	8225101
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
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 intraoperative, there is stimulation detection problem with probe.Difficulty for the operator to detect stimulation as changed appearance of the stimulator (the tip of the stimulator is more rounded than usual, making it difficult for the operator to detect stimulation).There was no patient injury.
Additional Manufacturer Narrative
Correction for manufacturer details.H3: analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.H6: fdm b17 and fdr c20 are no longer applicable.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant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
Section d3 and d4 has been updated.H3: product analysis found that the device and an open pouch were placed in a resealable bag and returned in a plastic sleeve.The pouch was open from 3 of 4 sides and the open sides of the pouch were stapled.There was no damage noted in the construction of the returned device and no contamination observed on the device.The probe tip was compared to the reference probe tip and found no issues with the returned probe tip.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 probe tip was placed securely into the handle with no issues.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 was no intermittent behavior while manipulating the tip, connector, or the wire.There were no issues observed during the analysis of the returned device.The complaint was not confirmed, no out of s pecification condition was observed.H6: fdm b21, fdr c21 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 FL 11500 ; DR 11500
• Manufacturer (Section G): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo FL 11500 ; DR 11500
• Manufacturer Contact: justin ellis ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635265677
• MDR Report Key: 22111926
• Report Number: 1045254-2025-01428
• Device Sequence Number: 6950899
• Product Code: ETN
• UDI-Device Identifier: 00763000417024
• UDI-Public: (01)00763000417024(17)330128(10)0230590826
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2025

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: 0230590826
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: 06/04/2025; 07/07/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 06/30/2025; 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2025
• 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