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	Insufficient Information (4580)
Date of Event	02/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The other adverse events issues questionnaire was submitted with limited information.There are no potential causes of "incapacitation" as there have been no previous reports of "incapacitation." information regarding the cause of the patient being "incapacitated," whether an mri was performed, or what was meant by "incapacitated" is not available at this time.The stimulator is used to treat pain.The cause of the patient being "incapacitated" 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 issue rates remain acceptably low; thus, a capa is not required at this time.Other adverse events issue rates will continue to be tracked and trended.
Event or Problem Description
On (b)(6) 2025, support received a call from the icu department for (b)(6) requesting mri clearance on a patient who was incapacitated.The icu nurse was going to relay the information to the radiologist to make a decision on performing an mri.As of february 13, 2025, several attempts have been made to contact the patient without success.Curonix is unable to confirm if an mri was performed, what was meant by "incapacitated", or current patient status.A supplemental report will be submitted as information becomes available.

• Brand Name: FREEDOM SPINAL CORD STIMULATOR
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): CURONIX LLC; 1310 park central blvd s; pompano beach FL 33064
• Manufacturer (Section G): CURONIX LLC; 1310 park central blvd s; pompano beach FL 33064
• Manufacturer Contact: tena jimmerson ; 1310 park central boulevard s.; pompano beach, FL 33064 ; 8009655134
• MDR Report Key: 21454195
• Report Number: 3010676138-2025-00036
• Device Sequence Number: 4605991
• Product Code: GZB
• UDI-Device Identifier: 00818225020693
• UDI-Public: (01)00818225020693(17)211101
• 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: 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): 02/24/2025

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: 11/01/2021
• Device Model Number: FR8A-RCV-A0
• Device Lot Number: SWO191103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 02/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2019
• 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
• Patient Age: 78 YR
• Patient Sex: Female