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 Code	Shock from Patient Lead(s) (3162)
Date of Event	08/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported periodic uncomfortable stimulation.The frequency was lowered on the transmitter assemblies and as of (b)(6) 2026, the shocking sensations have gone away and the patient is getting marginal relief.
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 was ruled out.However, after lowering the frequency on the transmitter assemblies, the shocking sensations have gone away and the patient is getting marginal relief.The stimulator is used to treat pain.The cause of the reported issue is due to programming parameters as the shocking sensations were resolved after lowering the frequency on the transmitter assemblies (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 ; +1(800)965-5134
• MDR Report Key: 50356236
• Report Number: 3010676138-2026-00172
• Device Sequence Number: 21360213
• Product Code: GZF
• UDI-Device Identifier: 00850051034406
• UDI-Public: (01)00850051034406(17)280201
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 08/20/2026

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: SWO260223
• 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: Not provided
• Initial Report FDA Received Date: 08/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/02/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Transmitter Assembly SN:(b)(6) LN: 01704-DT; Transmitter Assembly SN:(b)(6) LN: 01704-DT
• Patient Age: 74 YR
• Patient Sex: Male