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 Codes	Discomfort (2330); Numbness (2415); Swelling/ Edema (4577)
Date of Event	10/18/2023
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 waa providing therapy when new pain occurred, changing the waa parameters intentionally or unintentionally, the patient having a non-curonix device implanted, not performing x-rays before and after the stimulation was experienced, device migration, and the patient experiencing new pain in a new area that is not targeted for therapy have been ruled out as potential causes.However, the patient has spinal stenosis and the implanting clinician believes the numbness was due to the lead placement.The stimulator is used to treat pain.The cause of the reported issue is due to patient being a poor candidate due to health, weight, age, or mental capacity as the patient has spinal stenosis (user error-clinician).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, capa is not required. unintended stimulation/new pain issue rates will continue to be tracked and trended.
Event or Problem Description
The patient reported numbness, immobility, discomfort, and severe swelling in their leg.An explant procedure was performed on (b)(6) 2023 which resolved the swelling.The patient is doing well, mobility has returned, and they are expected to be implanted with a new lead, however, a date has not been set.

• 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: 18143771
• Report Number: 3010676138-2023-00234
• Device Sequence Number: 17889441
• Product Code: GZB
• UDI-Device Identifier: 00818225020693
• UDI-Public: (01)00818225020693(17)240401
• 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: 2023
• Device Explanted 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): 11/15/2023

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
• Device Lot Number: SWO220428
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male