MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	FR4A-TRL-A0
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Bacterial Infection (1735); Skin Inflammation/ Irritation (4545)
Date of Event	11/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The other adverse events issues questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device off-label, migration, and inadvertently puncturing the bone or tissue during the procedure have been ruled out as potential causes.Additionally, picking or touching the wound and the patient having contraindicating conditions have been ruled out.However, non-compliance to the ifu was identified as the surgical site was closed using steri-strips and tegaderm.Per the freedom peripheral nerve stimulator system implantation of neurostimulator instructions for use, 05-20200 rev.7 "close the incisions using sterile skin closures and apply dressings.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.Although the cause of the reported issue is unknown, non-compliance to the ifu was identified as the surgical site was closed with steri-strips and tegaderm (user error-clinician).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.
Event or Problem Description
The patient reported redness and skin irritation after their trial neurostimulator was pulled.The patient was treated by urgent care and antibiotics were prescribed.A staph infection was identified and the patient was sent to the emergency department where iv antibiotics were prescribed.The patient was allergic to the first antibiotic.However, the second antibiotic cleared up the infection.The patient will be moving forward with the permanent implant although the implanting clinician wants to wait a few months to ensure safety.

• 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: 23809955
• Report Number: 3010676138-2025-00284
• Device Sequence Number: 7707693
• Product Code: GZF
• UDI-Device Identifier: 00850051034369
• UDI-Public: (01)00850051034369(17)270701
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 12/15/2025

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: FR4A-TRL-A0
• Device Lot Number: SWO250716
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2025
• 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
• Patient Age: 82 YR
• Patient Sex: Unknown