MAUDE Adverse Event Report: Curonix LLC Freedom Peripheral Nerve Stimulator

Model Number	STQ4-RCV-A0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	09/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was taken to the hospital on (b)(6) 2026 due to swelling in the lower extremity and concerns of infection.Antibiotics were prescribed the week prior after a follow up appointment with the implanting clinician.As of (b)(6) 2026, the patient completed their antibiotics, they are doing well, and resumed using the neurostimulator without issue.
Additional Manufacturer Narrative
The other adverse events issues issue questionnaire was reviewed for causes of the reported issue.Based on this review, implanting the device off-label, implanting the device too close to the targeted nerve, and inadvertently puncturing bone or tissue during the procedure have been ruled out.Additionally, the patient having pneumonia and dehydration have been ruled out.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 unknown.The investigation findings do not lead to a clear conclusion about the cause of the reported issue.Therefore, conclusion has been selected as unable to determine root cause.Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in other adverse events issues.Other adverse events issues rates remain acceptably low; thus, a capa is not required.Other adverse events issues 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 ; +1(800)965-5134
• MDR Report Key: 50886588
• Report Number: 3010676138-2026-00200
• Device Sequence Number: 15900557
• Product Code: GZF
• UDI-Device Identifier: 00850051034406
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 09/24/2026

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
• Device Lot Number: SWO260729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/14/2026
• 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: 72 YR
• Patient Sex: Male