MAUDE Adverse Event Report: Curonix LLC Freedom Peripheral Nerve Stimulator

Model Number	STQ4-RCV-A0, STQ4-RCV-B0
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The loss of therapy/no therapy questionnaire was reviewed for potential causes of the reported issue.Based on this review, never achieving therapy, implanting the device off-label, not performing an x-ray immediately after the procedure to confirm placement, inadequate fixation, and no attempts to change the programs on the transmitter assembly have been ruled out.Additionally, improper surgical technique has been ruled out.However, the commercial team member met with the patient to re-educate them on where to place the transmitter assembly antenna to receive adequate therapy.The stimulator is used to treat pain.The cause of reported issue is due to transmitter assembly antenna placement as therapy was restored after the patient was re-educated on proper use (user error - patient).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in loss of therapy/no therapy.Loss of therapy/no therapy rates remain acceptably low; thus, a capa is not required at this time.Loss of therapy/no therapy rates will continue to be tracked and trended.
Event or Problem Description
The patient reported increased pain in their lower leg and no longer receiving pain relief.On (b)(6) 2026, the commercial team member met with the patient and re-educated them on where to place the transmitter assembly antenna to receive adequate therapy.Additionally, the power index was decreased on the transmitter assembly.Therapy has been restored and the pain resolved.The patient will follow-up with the commercial team member to see how therapy is going.

• 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: 50074049
• Report Number: 3010676138-2026-00145
• Device Sequence Number: 10251044
• Product Code: GZF
• UDI-Device Identifier: 00850051034406
• UDI-Public: (01)00850051034406(17)280201
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/29/2026

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, STQ4-RCV-B0
• Device Lot Number: SWO260212, SWO260313
• 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: 07/01/2026
• Initial Report FDA Received Date: 07/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/04/2026
• 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
• Patient Age: 75 YR
• Patient Sex: Female