MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	STQ4-RCV-B0, STQ4-RCV-A0
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	06/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported many instances of "shocks" in their cheek while wearing the device.The patient was advised to stop using the device until the programs on the transmitter assembly could be changed.On (b)(6) 2026, the programs on the transmitter assembly were lowered, the patient was given a prescription of lidocaine spray and patches, and the patient was asked to not use their devices.The patient will try the new programs on the transmitter assembly when they return from a three-week holiday and their post-operative pain has subsided.The patient will follow-up with the hospital outpatient clinic.No further information is available at this time.
Additional Manufacturer Narrative
The unintended stimulation/new pain questionnaire was reviewed for potential causes of the reported issue.Based on this review, interference with a non-curonix device has been ruled out as a potential cause.Although the cause of the "shocks" is unknown, off-label use was identified as the device was implanted in the craniofacial region.Per the freedom peripheral nerve stimulator system implantation of neurostimulator instructions for use, 05-30200 rev.7 "the freedom pns system is not intended to treat pain in the craniofacial region." the stimulator is used to treat pain.The cause of the "shocks" is unknown.However, off-label use was identified as the device was implanted in the craniofacial region (user error-clinician).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: 25613357
• Report Number: 3010676138-2026-00113
• Device Sequence Number: 10143619
• Product Code: GZF
• UDI-Device Identifier: 00850051034406
• UDI-Public: (01)00850051034406(17)280201
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/24/2026

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-B0, STQ4-RCV-A0
• Device Lot Number: SWO241224, SWO260223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2026
• Initial Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2024
• 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 SN: (B)(6), LN: 01663OUS-DT.; TRANSMITTER SN: (b)(6), LN: 01663OUS-DT; TRANSMITTER SN: (b)(6), LN: 01663OUS-DT
• Patient Sex: Unknown