MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	FR8A-RCV-A0
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	10/16/2025
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 device after the expiration date, not prepping the surface of the skin with an antiseptic solution, improperly closing the surgical site, not irrigating the incision site with an antibiotic solution before closure, multiple tunneling attempts, and using inappropriate tools have been ruled out.However, the device is implanted in the supraorbital region of the face which is off-label use.Per the freedom peripheral nerve stimulator system implantation of neurostimulator instructions for use, 05-20200 rev 7, "the freedom pns system is not intended to treat pain in the craniofacial region." in addition, the implanting clinician nicked the patient's bone during the procedure which may have contributed to the swelling in the forehead.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 swelling is attributed to two identified root causes: off-label use as the device was implanted in the supraorbital region of the face (user error- clinician).Improper surgical technique as the implanting clinician nicked the patient's bone during the procedure (user-error clinician).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 reportedly experienced swelling in their forehead.However, the swelling was not visible and the labs were normal.An explant procedure was performed on (b)(6) 2025.As of (b)(6) 2025 the patient is experiencing some swelling although it has some improvement.

• 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: 23512591
• Report Number: 3010676138-2025-00256
• Device Sequence Number: 13178320
• Product Code: GZF
• UDI-Device Identifier: 00850051034284
• UDI-Public: (01)00850051034284(17)270301
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K171366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted 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): 11/10/2025

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: FR8A-RCV-A0
• Device Lot Number: SWO250328
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Unknown