MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	STQ4-RCV-A0, STQ4-SPR-B0
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Erosion (1750); Impaired Healing (2378)
Date of Event	02/11/2026
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 device off-label has been ruled out.Additionally, severe force being applied to the implant (patient fall, accident), excessive twisting or stretching, and the patient touching or picking at the wound have been ruled out.However, the patient is a poor surgical risk as they have a history of diabetes.Per the freedom peripheral nerve stimulator system implantation of neurostimulator instructions for use, 05-20200 rev.8 "poor surgical risks - peripheral nerve stimulators should not be used on patients who are poor surgical risks or patients with multiple illnesses, active general infections, or other potential surgical risks as identified by the clinician." 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 erosion and the receiver site never quite healing is unknown.However, the patient is a poor candidate due to age, weight, or mental capacity as the patient has diabetes (user error-clinician).The cause of the fractured neurostimulator is due to incorrect surgical technique as the surgeon used excessive force during the explant procedure which fractured the device (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 reported erosion.Additionally, the receiver site "never quite healed" and they could always feel a bump underneath the skin.Antibiotics were prescribed prophylactically and an explant procedure was scheduled for (b)(6) 2026.During the explant procedure, the neurostimulator broke at the circuitry and tines.The electrodes were left in place at the tibial flare and the patient has an appointment on (b)(6) 2026 with the orthopedic surgeon to discuss whether or not the remainder of the neurostimulator will be removed.As of (b)(6) 2026, the patient's wound is otherwise healing well, with no surrounding redness or drainage.The commercial team member has made several attempts to contact the patient regarding their appointment with the orthopedic surgeon.However, the attempts have been unsuccessful.No further information is available at this time.

• 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: 24583549
• Report Number: 3010676138-2026-00043
• Device Sequence Number: 18730788
• Product Code: GZF
• UDI-Device Identifier: 00818225020464
• UDI-Public: (01)00818225020464(17)221001
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K233162
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted 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): 03/12/2026

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: 10/01/2022
• Device Model Number: STQ4-RCV-A0, STQ4-SPR-B0
• Device Lot Number: SWO201029, SWO210516
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/02/2020
• 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: 70 YR
• Patient Sex: Female