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 Codes	Pain (1994); Numbness (2415)
Date of Event	06/26/2026
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 achieving paresthesia on the table, not performing an x-ray immediately after the implant procedure to confirm device placement, and inadequate fixation have been ruled out.However, excessive twisting or stretching was identified as the patient assisted an elderly person off the floor who had fallen which caused extreme pain and numbness.The stimulator is used to treat pain.The cause of the reported issue is due to excessive twisting or stretching, as the patient assisted an elderly person off the floor who had fallen (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 extreme pain in their neck, loss of therapy, as well as numbness to their fingertips on the left side.The patient was advised to continue using the neurostimulator and change the programs on their transmitter assembly, as needed.Additionally, x-rays were performed which confirmed device placement.As of (b)(6) 2026, the patient is doing well and reported their pain got better with time and they did not need to change the programs on their transmitter assembly.The implanting clinician advised light duty restrictions and ordered physical therapy.The patient will have a follow up appointment after physical therapy has been completed.No further issues have been reported.

• 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: 25807558
• Report Number: 3010676138-2026-00136
• Device Sequence Number: 15894006
• Product Code: GZF
• UDI-Device Identifier: 00850051034413
• UDI-Public: (01)00850051034413(17)280301
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 07/13/2026

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: SWO260320, SWO260320
• 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: 06/26/2026
• Initial Report FDA Received Date: 07/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2026
• 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: 56 YR
• Patient Sex: Female