MAUDE Adverse Event Report: Curonix LLC Freedom Peripheral Nerve Stimulator

Model Number	STQ4-RCV-A0
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Post Operative Wound Infection (2446); Fluid Discharge (2686)
Date of Event	09/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported an infection at the receiver site with clear liquid discharge off and on.Antibiotics were prescribed and an explant procedure was approved.Several attempts have been made to schedule the explant procedure.However, the patient refuses to move forward and does not want to take the device out.The physician is planning to speak to the patient again.No further information is available at this time.
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, and multiple tunneling attempts have been ruled out.Additionally, the patient touching or picking at the wound has been ruled out.However, the patient is a poor surgical risk as they are prone to infections.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." additionally, non-compliance to the ifu was identified as the surgical site was closed using staples."closures are usually done in two steps, with absorbable sutures for the deeper layer and either nonabsorbable or absorbable sutures for the superficial layer." 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 attributed to two identified root causes: patient is a poor candidate due to health, weight, age, or mental capacity as they are prone to infections (user error-clinician.) non-compliance to the ifu as the surgical site was closed using staples (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 ; +1(800)965-5134
• MDR Report Key: 50885184
• Report Number: 3010676138-2026-00198
• Device Sequence Number: 13450600
• Product Code: GZF
• UDI-Device Identifier: 00850051034406
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: SWO260212
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2026
• 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: 39 YR
• Patient Sex: Male