MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	STQ4-RCV-B0, STQ4-RCV-A0
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/02/2026
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 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, severe force being applied to the implant, the patient having contraindicating conditions, the patient having recently gone through an mri, and the patient having non-curonix devices implanted have been ruled out.The stimulator is used to treat pain.The cause of the loss of therapy and the new pain is due to migration.However, the cause of migration is unknown.The investigation findings do not lead to a clear conclusion about the cause of the migration.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 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 loss of therapy and pain from the neurostimulators poking them under the skin.Several attempts have been made to change the programs on the transmitter assembly without success.However, x-rays confirmed device migration.An explant procedure was performed on (b)(6) 2026.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: 25616395
• Report Number: 3010676138-2026-00114
• Device Sequence Number: 15728727
• Product Code: GZF
• UDI-Device Identifier: 00850051034406
• UDI-Public: (01)00850051034406(17)250801
• 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: 2024
• Device Explanted 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): 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: 09/01/2025
• Device Model Number: STQ4-RCV-B0, STQ4-RCV-A0
• Device Lot Number: SWO230913, SWO230807
• 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: 06/03/2026
• Initial Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/21/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Unknown