MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	FR4A-TRL-B0, FR4A-TRL-B0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The other adverse events issues questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device off-label, implanting the neurostimulator too close to the targeted nerve, and inadvertently puncturing bone or tissue during the procedure have been ruled out as potential root causes.Additionally, non-compliance to the ifu, severe force applied to the implant (fall, accident), excessive twisting, bending, or stretching, and incorrect transmitter assembly antenna placement have been ruled out.However, the area of pain was not near the neurostimulator implant and the burning sensation was not believed to be associated with the curonix device.The pain experienced by the patient is likely due to an acute flare of pain due to the inflammatory cycle which typically lasts 48-72 hours.The stimulator is used to treat pain.The as analyzed code was selected as no problem found as the patient experienced normal post-procedural pain (no fault found).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in other adverse events issues.Other adverse events issue rates remain acceptably low; thus, a capa is not required.Other adverse events issue rates will continue to be tracked and trended.
Event or Problem Description
The patient reported severe low back pain with radicular/sciatic symptoms burning to their foot.Additionally, the patient has a history of depression and reported significant mood alteration.The patient followed up with their primary care physician regarding the mood changes and completed the trial.Although the patient reported 40% pain relief from the trial, they did not have any functional improvements in their ability to stand or walk longer so they will not move to permanent implant.As of (b)(6) 2025, the back and radicular pain resolved and the patient is being treated for mood disorders/depression by their primary care physician.

• Brand Name: FREEDOM PERIPHERAL NERVE STIMULATOR
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): CURONIX LLC; 1310 park central blvd s; pompano beach FL 33064
• Manufacturer (Section G): CURONIX LLC; 1310 park central blvd s; pompano beach FL 33064
• Manufacturer Contact: tena jimmerson ; 1310 park central boulevard s.; pompano beach, FL 33064 ; 8009655134
• MDR Report Key: 21964256
• Report Number: 3010676138-2025-00092
• Device Sequence Number: 7264918
• Product Code: GZF
• UDI-Device Identifier: 00850051034383
• UDI-Public: (01)00850051034383(17)261201
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K171366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2025

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: Lay User/Patient
• Device Model Number: FR4A-TRL-B0, FR4A-TRL-B0
• Device Lot Number: SWO241202, SWO241115
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Initial Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2024
• 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 Age: 54 YR
• Patient Sex: Female