MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	FR4A-TRL-B0
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Post Operative Wound Infection (2446); Swelling/ Edema (4577)
Date of Event	03/03/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the neurostimulator after the expiration date, not prepping the skin with an antiseptic solution, and using incorrect tools have been ruled out.Additionally, improper surgical technique and the patient having contraindicating conditions have been ruled out.However, the patient had an incontinence episode directly following the trial procedure which wet the procedural leg and the dressing was not changed.Additionally, the patient did not wear their compression stockings during the trial period and had some swelling as a result.A curonix representative conducted a review of sterilization and packaging records for the respective product lot; curonix has confirmed that the product was delivered sterile, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.The stimulator is used to treat pain.The cause of the infection is due to patient non-compliance as the patient had an incontinence episode on the procedural leg and did not change their dressing as well as not wearing their compression stockings during the trial period (user error-patient).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in surgical issues.Surgical issue rates remain acceptably low; thus, a capa is not required at this time.Surgical issue rates will continue to be tracked and trended.
Event or Problem Description
The patient was told they had an infection at their trial pull appointment.Additionally, the patient experienced some swelling.Antibiotics were prescribed and the trial neurostimulator was pulled on the planned date of (b)(6), 2026.As of march 16, 2026, the patient completed all of their antibiotics and the swelling has reduced.No further issues have been reported.

• 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: 24735732
• Report Number: 3010676138-2026-00053
• Device Sequence Number: 18747248
• Product Code: GZF
• UDI-Device Identifier: 00850051034383
• UDI-Public: (01)00850051034383(17)261001
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K233162
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 03/30/2026

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: 10/01/2026
• Device Model Number: FR4A-TRL-B0
• Device Lot Number: SWO241003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/19/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male