MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	FR8A-TRL-B0, FR8A-TRL-A0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Numbness (2415)
Date of Event	08/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The unintended stimulation/new pain questionnaire was reviewed for potential causes of the reported issue.Based on this review, the questionnaire was completed by quality with limited information.The patient had another procedure a week before their trial implant procedure and the physician believes this may be causing their neurological symptoms.The physician does not believe the curonix devices relate to the patient's symptoms.The stimulator is used to treat pain.The cause of the reported issue is unrelated to the curonix device as the physician does not believe the curonix devices relate to the patient's symptoms (no fault found).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in unintended stimulation/new pain issues.Unintended stimulation/new pain issue rates remain acceptably low; thus, a capa is not required.Unintended stimulation/new pain issues rates will continue to be tracked and trended.
Event or Problem Description
The patient reported numbness, tingling, and weakness in their legs during their trial.The trial devices were pulled and the physician does not relate the patient's symptoms to the curonix devices.

• Brand Name: FREEDOM PERIPHERAL NERVE STIMULATOR
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): CURONIX LLC; 1310 park central boulevard s.; pompano beach FL 33064
• Manufacturer (Section G): CURONIX LLC; 1310 park central boulevard s.; pompano beach FL 33064
• Manufacturer Contact: alicia pagliaro ; 1310 park central boulevard s.; pompano beach, FL 33064 ; 8009655134
• MDR Report Key: 22978962
• Report Number: 3010676138-2025-00190
• Device Sequence Number: 8918281
• Product Code: GZF
• UDI-Device Identifier: 00850051034390
• UDI-Public: (01)00850051034390(17)260801
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 09/05/2025

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 Expiration Date: 08/01/2026
• Device Model Number: FR8A-TRL-B0, FR8A-TRL-A0
• Device Lot Number: SWO240830, SWO250115
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2025
• Initial Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2024
• 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: 65 YR
• Patient Sex: Unknown