MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	STQ4-RCV-B0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Pain (1994); Fluid Discharge (2686); Swelling/ Edema (4577)
Date of Event	05/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported their incision site suddenly swelled up and became "hard" with mild pain.Antibiotics were prescribed on (b)(6) 2026.The patient followed up on (b)(6) 2026 and noted the swelling improved and they have adhered to taking their antibiotics and discontinued use of the neurostimulator until the area has healed.The patient attended an additional follow-up appointment on (b)(6) 2026.The patient was instructed how to clean the wound appropriately as well as how to cover the wound while working and they were cleared from serious infection.It was noted the patient was doing well overall, the swelling was gone, the wound had scabbed over with minimal drainage, and the patient may continue use of the device while covering the incision with a bandage.Additional information was received on may 28, 2026.The commercial team member reported the incision site re-opened and the neurostimulator was visible and the implanting clinician was notified.No further information is available at this time.
Additional Manufacturer Narrative
The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device off-label, not performing an x-ray immediately after the procedure to confirm device placement, inadequate fixation, implanting a damaged neurostimulator, implanting the device after the expiration date, not prepping the surface of the skin with an antiseptic solution, not irrigating the incision site with an antibiotic solution before closure, improperly closing the surgical site, multiple tunneling attempts, using inappropriate tools, and not prescribing antibiotics pre-operatively have been ruled out.Additionally, the patient touching or picking at the wound, the patient having contraindicating conditions, and severe force being applied to the implant have been ruled out.A curonix representative conducted a review of sterilization and packaging records for the respective product lot; curonix has confirmed that the product was delivered sterile, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.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 surgical issues.Surgical issue rates remain acceptably low; thus, a capa is not required at this time.Surgical issue 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 ; 8009655134
• MDR Report Key: 25322364
• Report Number: 3010676138-2026-00090
• Device Sequence Number: 12078674
• Product Code: GZF
• UDI-Device Identifier: 00850051034413
• UDI-Public: (01)00850051034413(17)280301
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 05/28/2026

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: SWO260306
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male