MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	STQ4-RCV-A0, STQ4-RCV-B0
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Skin Infection (4544)
Date of Event	06/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported an infection in their left lower leg.An explant procedure was performed on (b)(6) 2026, i.V.Antibiotics were prescribed, and the patient stayed in the hospital for several days for observation.However, the dates of the hospital observation and serial number of the device that was explanted are unknown.The patient is doing better, currently taking oral antibiotics, wearing a wound vac, and the wound vac dressing is being changed every few days.The commercial team member has made several attempts to contact the patient for further information without success.
Additional Manufacturer Narrative
The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, the questionnaire was completed with limited information.However, the patient is a poor surgical risk as they have type 2 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 reported issue is due to the patient being a poor candidate due to age, weight, or mental capacity as the patient is a poor surgical risk as they have type 2 diabetes (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.

• 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: 25659393
• Report Number: 3010676138-2026-00116
• Device Sequence Number: 13363719
• Product Code: GZF
• UDI-Device Identifier: 00850051034406
• UDI-Public: (01)00850051034406(17)270501
• 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: 2025
• 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): 06/29/2026

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 Model Number: STQ4-RCV-A0, STQ4-RCV-B0
• Device Lot Number: SWO250516, SWO250228
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Initial Report FDA Received Date: 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2025
• 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; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male