MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	FR8A-TRL-B0, FR8A-TRL-A0
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Headache (1880); Neck Pain (2433)
Date of Event	02/07/2026
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, not prepping the surface of the skin with an antiseptic solution, not irrigating the incision site with an antibiotic solution before closure, using inappropriate tools, and not using antibiotics pre-operatively have been ruled out.Additionally, touching or picking at the wound, improperly closing the surgical site, implanting the device off-label, and the patient having contraindicating conditions have been ruled out.However, non-compliance to the ifu was identified as the patient had a pain pump implanted.Per the freedom peripheral nerve stimulator system implantation of neurostimulator instructions for use, 05-20200 rev.8 "active implantable or body-worn medical devices - safety has not been established for patients who use the freedom scs/pns system with other active implantable or body- worn medical devices.These devices include other neurostimulation systems, insulin pumps, automated external defibrillators (aed), cochlear implants, and wearable medical sensors.Malfunction and/or damage could occur to either system, harming to the patient or nearby people." in addition, a surgical issue was identified as multiple tunneling attempts were performed between the two incisions.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.Although, meningitis and infection were not confirmed, two as analyzed codes were selected: non-compliance to the ifu as the patient had a pain pump implanted (user error-clinician).Surgical issue as multiple tunneling attempts were performed between the two incisions (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 went to the emergency department after experiencing headache and neck pain, which raised concern for possible meningitis.Cultures were obtained.However, no growth was observed on cultures and an infection was not confirmed.The patient was hospitalized from on (b)(6) 2026, antibiotics were prescribed prophylactically, and the devices were pulled early on (b)(6) 2026.As of on (b)(6) 2026, the patient is stable and at home.

• 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: 24490858
• Report Number: 3010676138-2026-00038
• Device Sequence Number: 14725547
• Product Code: GZF
• UDI-Device Identifier: 00850051034390
• UDI-Public: (01)00850051034390(17)270501
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K233162
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 03/02/2026

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: FR8A-TRL-B0, FR8A-TRL-A0
• Device Lot Number: SWO250516, SWO250516
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2025
• 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: Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male