MAUDE Adverse Event Report: CURONIX LLC FREEDOM SPINAL CORD STIMULATOR

Model Number	FR8A-RCV-A0, FR8A-SPR-B0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The other adverse events issues questionnaire was completed by quality with limited information.Potential causes of pain are programming parameters, interference with non-curonix device, change in posture or proximity of electrode to target nerve resulting in stimulation of nerves outside of the target nerve, stimulator electrical failure, interference from other electro magnetic sources, off-label use and patient contraindicating conditions.The patient was instructed to wear the device 30 minutes prior to getting up.Additionally, the device was reprogrammed and the patient's pain levels dropped significantly.The stimulator is used to treat pain.The cause of the hospitalization is unknown.However, the cause of not receiving pain relief is due to incorrect programming parameters (user error - clinical representative).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, capa is not required. other adverse events issue rates will continue to be tracked and trended.
Event or Problem Description
The patient reported not receiving any pain relief and being hospitalized two weeks after the permanent implant procedure.The cause for hospitalization is unknown as the patient and the hospital could not provide a reason.However, the patient reported feeling paralysis when they reach over their head prior to the implant.Additionally, the patient mentioned feeling pain in the morning as they do not wear the device at night.The patient was instructed to wear the device 30 minutes prior to getting up.Additionally, the device was reprogrammed and the patient's pain levels dropped significantly and the device is working well.

• 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: 17453741
• Report Number: 3010676138-2023-00160
• Device Sequence Number: 7341574
• Product Code: GZB
• UDI-Device Identifier: 00818225020693
• UDI-Public: (01)00818225020693(17)240401(01)00818225020648(17)240401(21)2B14815-43
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K182720
• 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): 08/03/2023

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: 04/01/2024
• Device Model Number: FR8A-RCV-A0, FR8A-SPR-B0
• Device Lot Number: SWO220428, SWO220428
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2022
• 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: 62 YR
• Patient Sex: Male