MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	STQ4-SPR-B0, STQ4-RCV-A0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Undesired Nerve Stimulation (1980)
Date of Event	03/17/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported feeling warmth and a tingling sensation during an mri procedure.The mri was aborted immediately and the tingling and warmth at the implant site are gone.On (b)(6) 2026, the commercial team member met the patient.The patient reported they are still feeling a tingling sensation when using the device and not receiving much therapy.The programs were changed on the transmitter assembly.As of on (b)(6) 2026, the patient reported their pain is doing better and they are not feeling the buzzing or tingling sensation since the programs were changed on the transmitter assembly.
Additional Manufacturer Narrative
The issues after an mri questionnaire was reviewed for potential causes of the reported issue.Based on this review, using the incorrect type of mri bore, the patient experiencing a fall, being injured, or performing strenuous activities since implantation, the patient having any other implanted pins/screws/devices, and migration have been ruled out.A potential cause of the reported issue is the mri facility not following the ifu for mri for the appropriate stimulator model.The stimulator is used to treat pain.The cause of the warmth and tingling sensation during the mri is unknown.The investigation findings do not lead to a clear conclusion about the cause of the reported issue.Therefore, the conclusion has been selected as unable to determine the 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 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: 24897028
• Report Number: 3010676138-2026-00060
• Device Sequence Number: 8677454
• Product Code: GZF
• UDI-Device Identifier: 00818225020495
• UDI-Public: (01)00818225020495(17)240701
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K233162
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 04/16/2026

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: 07/01/2024
• Device Model Number: STQ4-SPR-B0, STQ4-RCV-A0
• Device Lot Number: SWO220726, SWO220726
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2026
• Initial Report FDA Received Date: 04/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/2022
• 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: 24 YR
• Patient Sex: Unknown