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	Pain (1994)
Date of Event	08/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The issues after an mri questionnaire was reviewed for potential causes of the reported issue.Based on this review, the mri facility not following the ifu for the appropriate neurostimulator model, the patient experiencing a fall, injury, or performing strenuous activities since the implant, and the patient having other implanted pins/screws/devices have been ruled out as potential causes.However, there were multilevel degenerative changes involved in the thoracic spine.The stimulator is used to treat pain.The cause of the dull aching is unrelated to the curonix device as imaging revealed multilevel degenerative changes involved in the thoracic spine (no fault found).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in issues after an mri issues.Issues after an mri issue rates remain acceptably low; thus, a capa is not required at this time.Issues after an mri issue rates will continue to be tracked and trended.
Event or Problem Description
The patient reported dull aching in their thoracic spine area two weeks after an mri.Although the pain has decreased over time, it has not gone away.X-rays have not been performed to confirm device placement as the patient has been traveling for work.The commercial team member noted the device is working for its intended purpose.However, the patient would like adjustments to improve the quality of therapy.Additional information was provided on september 16, 2024.X-rays were performed which showed the device position was unchanged compared to images taken in 2020.However, there were multilevel degenerative changes involved in the thoracic spine.The patient status remains unchanged.

• 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: 20232313
• Report Number: 3010676138-2024-00182
• Device Sequence Number: 7961297
• Product Code: GZB
• UDI-Device Identifier: 00818225020693
• UDI-Public: (01)00818225020693(17)210201
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K182720
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 09/16/2024

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: 02/01/2021
• Device Model Number: FR8A-RCV-A0
• Device Lot Number: SWO190202
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 09/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/21/2018
• 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: 49 YR
• Patient Sex: Female