MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	FR8A-RCV-A0, FR8A-RCV-B0
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	07/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported a zapping sensation when the neurostimulator was not in use.The commercial team member changed the programs on the transmitter assembly and moved the electrodes which resolved the report of zapping sensations.No further issues have been reported.
Additional Manufacturer Narrative
The unintended stimulation/new pain questionnaire was reviewed for potential causes of the reported issue.Based on this review, the patient having another non-curonix device implanted has been ruled out as a potential cause.After the programs on the transmitter assembly were changed and the electrodes were moved, the report of zapping sensations was resolved.The stimulator is used to treat pain.The cause of the zapping sensations is due to programming parameters as the issue was resolved after the programs on the transmitter assembly were changed and the electrodes were moved (user error-commercial team member).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.

• 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: 22790124
• Report Number: 3010676138-2025-00165
• Device Sequence Number: 8314935
• Product Code: GZF
• UDI-Device Identifier: 00850051034284
• UDI-Public: (01)00850051034284(17)270301
• Combination Product (Y/N): N
• Initial Reporter Country: QA
• 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): 08/12/2025

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: FR8A-RCV-A0, FR8A-RCV-B0
• Device Lot Number: SWO250328, SWO250123
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2025
• 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
• Patient Age: 23 YR
• Patient Sex: Male