MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	STQ4-RCV-B0, STQ4-RCV-A0
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/15/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The loss of therapy/no therapy questionnaire was reviewed.Based on this review, the incorrect questionnaire was completed.However, the patient had a non-curonix scs device implanted.Per the freedom peripheral nerve stimulator system implantation of neurostimulator instructions for use, 05-20200 rev.8 "active implantable or body-worn medical devices - safety has not been established for patients who use the freedom pns system with other active implantable or body-worn medical devices.These devices include other neurostimulation systems, insulin pumps, automated external defibrillators (aed), cochlear implants, and wearable medical sensors.Malfunction and/or damage could occur to either system, harming the patient or nearby people." the stimulator is used to treat pain.The cause of the reported issue is due to interference from a non-curonix device as the non-curonix scs device caused extreme pain where the pns devices are implanted (user error- clinician).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 their non-curonix scs trial device interfered and irritated their curonix pns devices.The patient noted the non-curonix scs implant caused extreme pain where the pns devices are implanted and requested an explant procedure of their curonix devices.An explant procedure was performed on (b)(6) 2026.

• 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: 25166897
• Report Number: 3010676138-2026-00077
• Device Sequence Number: 18772669
• Product Code: GZF
• UDI-Device Identifier: 00850051034413
• UDI-Public: (01)00850051034413(17)270401
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K233162
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 05/13/2026

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-B0, STQ4-RCV-A0
• Device Lot Number: SWO250415, SWO250415
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2025
• 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: 54 YR
• Patient Sex: Unknown