MAUDE Adverse Event Report: CURONIX LLC FREEDOM SPINAL CORD STIMULATOR

Model Number	FR8A-RCV-A0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dizziness (2194); Shaking/Tremors (2515)
Date of Event	10/13/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The other adverse events issues questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device off-label, device migration, and inadvertently puncturing bone or tissue have been ruled out.Other potential causes of the reported issue include: programming parameters, interference from a non-curonix device, the patient having contraindicating conditions, and severe force applied to the implant.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, conclusion has been selected as unable to determine root cause.Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in other adverse events issues.Other adverse events issues rates remain acceptably low; thus, a capa is not required.Other adverse events issues rates will continue to be tracked and trended.
Event or Problem Description
The patient reported moderate internal tremors throughout their entire body.The patient turned off their device.However, the tremors did not stop and the patient continued to use the device.Over the next few weeks, the patient also developed constant mild dizziness and was referred to a neurologist.An x-ray was performed which revealed devices running the full length of their spine.The internal tremors and dizziness intensified and the patient discontinued use of the device.The symptoms have largely resolved.No further information is available at this time.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR
• Common Device Name: SPINAL CORD 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: 23471367
• Report Number: 3010676138-2025-00252
• Device Sequence Number: 15865251
• Product Code: GZB
• UDI-Device Identifier: 00850051034024
• UDI-Public: (01)00850051034024(17)260401
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K182720
• 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): 11/04/2025

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: 04/01/2026
• Device Model Number: FR8A-RCV-A0
• Device Lot Number: SWO240430
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2023
• 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: 71 YR
• Patient Sex: Male