MAUDE Adverse Event Report: Curonix LLC Freedom Peripheral Nerve Stimulator

Model Number	FR4A-TRL-A0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported bleeding at the incision site after their trial implant procedure.The patient went to the hospital, the bandages were removed, the steris-strips were left in tact, pressure was applied to stop the bleeding, and the wound was redressed in order for the patient to continue the trial.As of (b)(6)2026, the bleeding has stopped.
Additional Manufacturer Narrative
The surgical issue questionnaire was reviewed for potential causes of the reported issue.However, the patient is on blood thinners and was not instructed to stop them which likely contributed to the bleeding after the implant procedure.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 bleeding after the implant procedure is unrelated to the curonix device as the patient was on blood thinners and was not instructed to stop them (no fault found).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 ; +1(800)965-5134
• MDR Report Key: 50808902
• Report Number: 3010676138-2026-00196
• Device Sequence Number: 8543183
• Product Code: GZF
• UDI-Device Identifier: 00850051034369
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 09/17/2026

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 Expiration Date: 08/01/2026
• Device Model Number: FR4A-TRL-A0
• Device Lot Number: SWO260805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2026
• 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
• Patient Age: 75 YR
• Patient Sex: Female