MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	STQ4-RCV-A0, STQ4-SPR-B0
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	08/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reportedly experienced a shock in the implant region while getting a massage.X-rays were performed which ruled out migration.As of (b)(6) 2025, the patient has not experienced any additional shocks, the patient is doing better and continues to use the device as they were prior to the shock.It is unknown which neurostimulator emitted the shock.Therefore, both devices were included in the investigation.
Additional Manufacturer Narrative
The unintended stimulation/new pain questionnaire was reviewed.The questionnaire was completed by quality with limited information.The patient experienced a shock while receiving a massage in the implant region.Additionally, the transmitter assembly was in use when the shock occurred.Per the freedom peripheral nerve stimulator system implantation of neurostimulator instructions for use, 05-20200 rev.7, "unexpected changes in stimulation - electromagnetic interference, changes in posture, and other activities can cause a perceived increase in stimulation.Some patients have described this as a jolting or shocking sensation.Before engaging in activities that could become unsafe, the system should be turned off.Discuss these activities with the clinician." the stimulator is used to treat pain.The cause of the shock is due to non-compliance to the ifu as the patient received a shock while receiving a massage in the implant region (user error-patient).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: 23027950
• Report Number: 3010676138-2025-00201
• Device Sequence Number: 9454830
• Product Code: GZF
• UDI-Device Identifier: 00818225020464
• UDI-Public: (01)00818225020464(17)231201
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K171366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 09/11/2025

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: 12/01/2023
• Device Model Number: STQ4-RCV-A0, STQ4-SPR-B0
• Device Lot Number: SWO211209A, SWO220118
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2021
• 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: 55 YR
• Patient Sex: Female