MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	STQ4-RCV-A0, STQ4-RCV-B0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Numbness (2415)
Date of Event	06/01/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The other adverse events issues issue questionnaire was reviewed for causes of the reported issue.Based on this review, the questionnaire was completed with limited information.Potential causes of the reported issue include: programming parameters, migration, interference from a non-curonix device, and severe force being applied to the implant.The stimulator is used to treat pain.The cause of the numbness is unknown.The investigation findings do not lead to a clear conclusion about the cause of the reported issue.Therefore, conclusion has been selected as unable to determine root cause.Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in other adverse events issues.Other adverse events issue rates remain acceptably low; thus, a capa is not required.Other adverse events issue rates will continue to be tracked and trended.
Event or Problem Description
The patient reported vibrations going up their neck, jaw, and ear lobe where they feel numbness whether the device is on or off.The commercial team member recommended the patient take a "stimulation holiday" and see a physician to check for device migration.After the "stimulation holiday," the patient reported the numbness was the same.However, it does help with their chronic neck pain.As of (b)(6) 2026, the patient is doing fine and saw an orthopedic physician where images were taken.However, results of the imaging have not been provided.No further information is available at this time.

• 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: 25612574
• Report Number: 3010676138-2026-00111
• Device Sequence Number: 5533974
• Product Code: GZF
• UDI-Device Identifier: 00850051034413
• UDI-Public: (01)00850051034413(17)270401
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K233162
• 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): 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 Expiration Date: 09/01/2026
• Device Model Number: STQ4-RCV-A0, STQ4-RCV-B0
• Device Lot Number: SWO240910, SWO250415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2026
• Initial Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/22/2024
• 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
• Patient Age: 83 YR
• Patient Sex: Female