MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ACCURIAN; GENERATOR, LESION, RADIOFREQUENCY

Model Number	APSC02
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Nerve Damage (1979)
Date of Event	09/01/2025
Type of Reportable Event	Serious Injury
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 following a procedure using the accurian enhanced radiofrequency (rf) probe with a treatment site of the femoral nerve.Initially an issue occurred described as a femoral nerve injury and subsequently updated to a burn.The patient is still under treatment for the injury.Standard treatment therapy was administered, and pre-loaded settings within the accurian generator were used.Education was provided prior to the procedure, and the unit performing rf ablation conducts procedures multiple times per week.The standard enhanced workflow was followed.It is believed the issue may have been due to a secondary transfer of energy due to the patient having a knee replacement on the treatment side.A diathermy pad was placed on the opposite side.Information was received again indicating a possible nerve injury.
Event or Problem Description
It was reported that the nerve injury and burn presented after the procedure at a follow up appointment.The cause was not determined, but it was believed to be due to the treatment and positioning and knee replacement.The nerve injury was reported to be resolved.
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.

• Brand Name: ACCURIAN
• Common Device Name: GENERATOR, LESION, RADIOFREQUENCY
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: justin ellis ; 8200 coral sea street ne mvs21; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 23424974
• Report Number: 2182207-2025-02970
• Device Sequence Number: 9799059
• Product Code: GXD
• UDI-Device Identifier: 00763000153458
• UDI-Public: (01)00763000153458(17)271003(10)BY24J009
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K181864
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: APSC02
• Device Catalogue Number: APSC02
• Device Lot Number: BY24J009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 12/08/2025
• Date Device Manufactured: 09/18/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male