MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	FR8A-TRL-A0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	06/10/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The unintended stimulation/new pain questionnaire was reviewed for potential causes of the reported issue.Potential causes of the reported issue are programming parameters, migration, interference from a non-curonix device, patient is a poor candidate due to health, weight, age, mental capacity, severe force applied to implant (patient fall, accidents), and off-label use.The stimulator is used to treat pain.The cause of the reported issue is unknown.The investigation findings do not lead to a clear conclusion about the cause of the reported issue.Therefore, the conclusion has been selected as unable to determine the root cause.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, a capa is not required.Unintended stimulation/new pain issues rates will continue to be tracked and trended.
Event or Problem Description
The patient reported a burning sensation in their knee, around the neurostimulator, after their implant procedure.The device was off for two days.However, the burning sensation never went away.Steroids were prescribed to take if the burning sensation did not go away and the neurostimulator was pulled early on (b)(6) 2024.The patient is doing fine and they are no longer experiencing the burning sensation.

• Brand Name: FREEDOM PERIPHERAL NERVE STIMULATOR
• Common Device Name: PERIPHERAL NERVE 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: 19629093
• Report Number: 3010676138-2024-00125
• Device Sequence Number: 20682790
• Product Code: GZF
• UDI-Device Identifier: 00850051034376
• UDI-Public: (01)00850051034376(17)260201
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K171366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 06/27/2024

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: 02/01/2026
• Device Model Number: FR8A-TRL-A0
• Device Lot Number: SWO240216
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2023
• 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: 57 YR
• Patient Sex: Female