MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	STQ4-RCV-B0
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Abscess (1690); Pain (1994); Blister (4537)
Date of Event	04/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported pain in their knee due to a blister at the receiver site, after their dog scratched them.On (b)(6) 2026, the provider observed a large abscess at the receiver site and an explant procedure was scheduled for (b)(6) 2026.However, the explant procedure was cancelled, as well as the rescheduled explant procedure on (b)(6) 2026 as the patient did not show up.On (b)(6) 2026, the patient went to the emergency room where the abscess was lanced.On (b)(6) 2026, antibiotics were prescribed and an explant procedure was performed.As of (b)(6) 2026, the commercial team member has tried contacting the patient regarding the status of the blister and abscess several times.However, they have been unsuccessful.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 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, multiple tunneling attempts, and using incorrect tools have been ruled out.However, patient non-compliance was identified as the patient's dog scratched them, leading to a blister and a large abscess at the receiver site.Additionally, non-compliance to the ifu was identified as the incision was closed using a topical skin adhesive.Per the freedom peripheral nerve stimulator system implantation of neurostimulator instructions for use, 05-20200 rev.8 "close the incisions using sterile skin closures and apply dressings.Closures are usually done in two steps, with absorbable sutures for the deeper layer and either nonabsorbable or absorbable sutures for the superficial layer.Apply dressings as needed." 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 blister and abscess is due to patient non-compliance (touching or picking at wound) as the patient's dog scratched them (user error-patient).Additionally, non-compliance to the ifu was identified as the receiver site was closed using topical skin adhesive (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.

• 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: 25260937
• Report Number: 3010676138-2026-00087
• Device Sequence Number: 10544911
• Product Code: GZF
• UDI-Device Identifier: 00850051034413
• UDI-Public: (01)00850051034413(17)270101
• 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: 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): 05/22/2026

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: SWO250115
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/19/2024
• 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: 80 YR
• Patient Sex: Female