MAUDE Adverse Event Report: CURONIX LLC FREEDOM SPINAL CORD STIMULATOR

Model Number	FR8A-SPR-B0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	10/23/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was reportedly hospitalized from (b)(6) 2025 through (b)(6) 2025 with bad staph infection.Iv antibiotics were prescribed for the infection.The infection was the result of a procedure to swap out the battery on their non-curonix scs system which was performed on (b)(6) 2025.The patient is waiting for an mri on (b)(6) 2025, and for new labs to be drawn.No further information is available at this time.
Additional Manufacturer Narrative
The other adverse events issues issue questionnaire was reviewed for causes of the reported issue.Based on this review, implanting the device in an off-label location, implanting the device too close to the targeted nerve, migration, and inadvertently puncturing the bone or tissue during the procedure have been ruled out as potential causes.However, non-compliance to the ifu has been identified as the patient has a non-curonix scs system implanted.In addition, the patient is a poor surgical risk as the patient is reportedly immunocompromised.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.Although non-compliance to the ifu was identified and the patient is a poor surgical risk, the infection was unrelated to the curonix device.The cause of the infection is unrelated to the curonix device as the infection was caused by the replacement procedure of their non-curonix scs device (no fault found).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.

• 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: 23573030
• Report Number: 3010676138-2025-00261
• Device Sequence Number: 21332196
• Product Code: GZB
• UDI-Device Identifier: 00818225020648
• UDI-Public: (01)00818225020648(17)220901
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K182720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 11/17/2025

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: 09/01/2022
• Device Model Number: FR8A-SPR-B0
• Device Lot Number: SWO200904
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2020
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female