MAUDE Adverse Event Report: Curonix LLC Freedom Peripheral Nerve Stimulator

Model Number	STQ4-RCV-B0
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During an implant procedure, the implanting clinician was unable to get consistent stim artifact and cmap post suturing.As a result, the patient was under anesthesia for longer than 30 minutes.The neurostimulator was explanted and the implant procedure was aborted.
Additional Manufacturer Narrative
The loss of therapy/no therapy questionnaire was reviewed.Based on this review, not performing an x-ray immediately after the implant procedure to confirm device placement, and no attempts to change the programs on the transmitter assembly have been ruled out.The neurostimulator associated with the complaint was returned for investigation.The investigation is currently in progress and has not yet been completed.The investigation will be updated when the investigation has been completed.The stimulator is used to treat pain.The cause of the reported issue is unknown.The investigation findings do not lead to a clear conclusion about the cause of the reported issue.Therefore, the conclusion has been selected as unable to determine the 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.

• 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: 50084192
• Report Number: 3010676138-2026-00148
• Device Sequence Number: 18727745
• Product Code: GZF
• UDI-Device Identifier: 00850051034413
• UDI-Public: (01)00850051034413(17)280601
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K233162
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 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-B0
• Device Lot Number: SWO260617
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/27/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2026
• Initial Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2026
• 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: 68 YR
• Patient Sex: Female