MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	FR8A-RCV-A0
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	11/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, 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 incorrect tools, and not prescribing antibiotics pre-operatively have been ruled out.However, the patient is a poor candidate as they have an allergy to platinum iridium which is present in the neurostimulator.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 rash is due to the patient being a poor candidate due to health, weight, age, or mental capacity as the patient has an allergy to the platinum iridium which is present in the neurostimulator (user error-clinician).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.
Event or Problem Description
The patient reported a red rash which spread across their body about two weeks after the neurostimulator was implanted.The patient was referred to a dermatologist, allergy testing was performed, and an allergy to platinum iridium was found.An explant procedure was performed on (b)(6) 2025 without any issues.

• 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: 23607459
• Report Number: 3010676138-2025-00269
• Device Sequence Number: 18454025
• Product Code: GZF
• UDI-Device Identifier: 00850051034284
• UDI-Public: (01)00850051034284(17)270501
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K171366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 11/20/2025

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 Model Number: FR8A-RCV-A0
• Device Lot Number: SWO250516
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Initial Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2025
• 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: 25 YR
• Patient Sex: Male