MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	STQ4-SPR-B0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cellulitis (1768); Drug Resistant Bacterial Infection (4553); Swelling/ Edema (4577)
Date of Event	09/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The other adverse events issues issue questionnaire was reviewed.Potential causes of the reported issue include: patient non-compliance/touching or picking at the wound, not irrigating the incision site with an antibiotic solution before closure, not prepping the skin with an antiseptic solution, using inappropriate tools, multiple tunneling attempts, and the patient having contraindicating conditions.However, the implanting clinician was very clear the curonix device had nothing to do with the wound on the patients leg.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 wound is unrelated to the curonix device.The provided information does not evidence that the curonix device contributed to the issue (no fault found).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in other adverse events issues.Other adverse events issue rates remain acceptably low; thus, a capa is not required.Other adverse events issue rates will continue to be tracked and trended.
Event or Problem Description
The patient reported a wound near their ankle which began eight months ago following cellulitis which caused significant edema.The patient was prescribed multiple rounds of antibiotics without improvement and is currently receiving lymphatic treatment with wraps and has not worn the device for over a year.As of (b)(6) 2025, antibiotic and anti-inflammatory cream was applied to the wound, the patient will follow-up and is very thankful and hopeful the implanting clinician will get the wound healed.Additional information was received on october 07, 2025.The wound tested positive for mrsa.However, the redness has gone down and the patient will continue to use the antibiotic cream with the anti-inflammatory as well.

• 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: 23302166
• Report Number: 3010676138-2025-00228
• Device Sequence Number: 4783699
• Product Code: GZF
• UDI-Device Identifier: 00818225020495
• UDI-Public: (01)00818225020495(17)210401
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 10/15/2025

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: 04/01/2021
• Device Model Number: STQ4-SPR-B0
• Device Lot Number: SWO190410
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/21/2018
• 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: Female