MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	FR4A-RCV-A0
Medical Device Problem Codes	Circuit Failure (1089); Use of Device Problem (1670)
Health Effect - Clinical Codes	Unspecified Infection (1930); Discomfort (2330)
Date of Event	05/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The unintended stimulation/new pain questionnaire was reviewed for potential causes of the reported issue.Based on this review, the questionnaire was completed by quality with limited information.Implanting the device off-label, not performing an x-ray immediately after the procedure to confirm placement, having another non-curonix device implanted, and migration have been ruled out as potential root causes.However, it was noted the patient has severe scarring at the implant site as well as the nerve at the time of the explant procedure.Additionally, the implant procedure was performed by open surgery which included exposure of the nerve and placement of the neurostimulator.Per curonix chief medical officer, general anesthesia can contribute to cholecystitis.Additionally, uncontrolled pain can trigger shingles.However, the chief medical officer does not believe that the device caused the pain.The neurostimulator associated with the complaint was returned for investigation.The investigation found circuit failure.The device failed the automated functional test on stimulator verification unit (tf-0029) and system failure was confirmed.In addition, there was evidence of liquid ingress (i.E.Efflorescence, oxidation) and the electrode wires were damaged due to corrosion.The stimulator is used to treat pain.The cause of the discomfort is due to non-compliance to the ifu as the implant procedure was performed by open surgery (user error-clinician).Additionally, circuit failure was observed as the neurostimulator failed the automated functional test (failure).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in unintended stimulation/new pain issues.Unintended stimulation/new pain issue rates remain acceptably low; thus, a capa is not required.Unintended stimulation/new pain issues rates will continue to be tracked and trended.
Event or Problem Description
The patient reported discomfort from the neurostimulator.Additionally, the patient reported an increased incidence of infections since their implant procedure (gangrenous cholecystitis with cholecystolithiasis and herpes zoster infection v1-v3 with mucosal involvement.An explant procedure was performed on (b)(6) 2025.The commercial team member was able to test the neurostimulator after the explant procedure and confirmed the blue light illuminated.

• Brand Name: FREEDOM PERIPHERAL NERVE STIMULATOR
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): CURONIX LLC; 1310 park central blvd s; pompano beach FL 33064
• Manufacturer (Section G): CURONIX LLC; 1310 park central blvd s; pompano beach FL 33064
• Manufacturer Contact: tena jimmerson ; 1310 park central boulevard s.; pompano beach, FL 33064 ; 8009655134
• MDR Report Key: 22214816
• Report Number: 3010676138-2025-00119
• Device Sequence Number: 8619432
• Product Code: GZF
• UDI-Device Identifier: 00850051034291
• UDI-Public: (01)00850051034291(17)26021
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K171366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted 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): 06/16/2025

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 Expiration Date: 02/01/2026
• Device Model Number: FR4A-RCV-A0
• Device Lot Number: SWO240216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2023
• 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 Sex: Female