MAUDE Adverse Event Report: CURONIX LLC FREEDOM SPINAL CORD STIMULATOR

Model Number	FR8A-TRL-A0
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	10/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The unintended stimulation/new pain questionnaire was reviewed for potential causes of the reported issue.Based on this review, the patient having a non-curonix device implanted has been ruled out.Potential causes of electric shock include programming parameters, device migration, patient contraindicating conditions, and severe force applied to the implant.The neurostimulator associated with the complaint was requested for investigation.However, it has not been received.The stimulator is used to treat pain.The cause of the electric shock is due programming parameters as the patient did not experience any additional shocks after the programs were changed on the transmitter assembly (user error-commercial team member).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in unintended stimulation/new pain issues.Unintended stimulation/new pain issue rates remain acceptably low; thus, a capa is not required.Unintended stimulation/new pain issues rates will continue to be tracked and trended.
Event or Problem Description
The patient reported an electrical shock throughout their body over 15 minutes after the programs on the transmitter assembly were changed.The patient was instructed to turn the device off and return to the office to change the programs.The programs on the transmitter were changed again, the patient did not experience any additional shocks, and the device remained implanted until their regularly scheduled appointment to pull the trial neurostimulator.
Event or Problem Description
The patient reported an electrical shock throughout their body over 15 minutes after the programs on the transmitter assembly were changed.The patient was instructed to turn the device off and return to the office to change the programs.The programs on the transmitter were changed again, the patient did not experience any additional shocks, and the device remained implanted until their regularly scheduled appointment to pull the trial neurostimulator.
Additional Manufacturer Narrative
The unintended stimulation/new pain questionnaire was reviewed for potential causes of the reported issue.Based on this review, the patient having a non-curonix device implanted has been ruled out.Potential causes of electric shock include programming parameters, device migration, patient contraindicating conditions, and severe force applied to the implant.The neurostimulator associated with the complaint was returned for investigation.The investigation found the neurostimulator passed the automated functional test on stimulator verification unit ((b)(6)).The device performed as expected and no non-conformances were found.The stimulator is used to treat pain.The cause of the electric shock is due programming parameters as the patient did not experience any additional shocks after the programs were changed on the transmitter assembly (user error-commercial team member).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in unintended stimulation/new pain issues.Unintended stimulation/new pain issue rates remain acceptably low; thus, a capa is not required.Unintended stimulation/new pain issues 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: 23607449
• Report Number: 3010676138-2025-00268
• Device Sequence Number: 9249430
• Product Code: GZB
• UDI-Device Identifier: 00850051034109
• UDI-Public: (01)00850051034109(17)270501
• 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,Followup
• Report Date (Section B): 04/01/2026

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: FR8A-TRL-A0
• Device Lot Number: SWO250516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2025
• 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: 76 YR
• Patient Sex: Female