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 Code	Burning Sensation (2146)
Date of Event	12/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported a burning sensation during a mri and the mri procedure was aborted.The patient has not experienced additional burning sensations and has continued using therapy.However, they reported no pain relief after the mri along with muscle tensions in their legs when using the device.The muscle tension was treated with kinesio tape and the patient saw a neurologist who prescribed medication.As of (b)(6) 2025, the pain is slightly better with the medication and an appointment is scheduled for (b)(6) 2026.No further information is available at this time.
Additional Manufacturer Narrative
The issues after an mri questionnaire was reviewed for potential causes of the reported issue.Based on this review, the patient experiencing a fall, being injured, or performing strenuous activities since implant, device migration, and the patient having any other implanted pins/screws/devices have been ruled out.Additionally, the transmitter assembly being in use during the mri has been ruled out.An additional potential cause is the mri scan not meeting mri requirements according to the instructions for use.However, the mri scan settings could not be obtained.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 issues after an mri.Issues after an mri rates remain acceptably low; thus, a capa is not required at this time.Issues after an mri rates will continue to be tracked and trended.

• 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: 23873286
• Report Number: 3010676138-2025-00294
• Device Sequence Number: 4552771
• Product Code: GZB
• UDI-Device Identifier: 00859619004875
• UDI-Public: (01)00859619004875(17)180601
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K182720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 12/22/2025

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: 06/01/2018
• Device Model Number: FR8A-RCV-A0
• Device Lot Number: 160619
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2016
• 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 Sex: Unknown