MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	FR8A-TRL-B0, FR8A-TRL-A0
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The trial-loss of therapy/no therapy questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device at an off-label location, not performing an x-ray immediately after the procedure to confirm placement, no attempts to reprogram the transmitter, and not securing (coiled and sterile dressing) the product to the body at the time of implant.Additionally, the patient could not recall any actions that would have caused the migration and they do not have any contraindicating conditions.The stimulator is used to treat pain.The cause the reported issue is migration.However, the cause of the migration is unknown.The investigation findings do not lead to a clear conclusion about the cause of migration.Therefore, conclusion code 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 loss of therapy/no therapy issues.Loss of therapy/no therapy issue rates remain acceptably low; thus, a capa is not required.Loss of therapy/no therapy issue rates will continue to be tracked and trended.
Event or Problem Description
The patient reported loss of therapy and was concerned with blood on their back.The patient returned to the office for reprogramming and troubleshooting.However, when the dressing was inspected, there was quite a bit of red fluid under occlusive dressing, and the lead placement could not be visually verified.The office staff took an x-ray and confirmed that the leads migrated.The implanting physician elected to pull the leads on (b)(6) 2024, and discontinue the trial.Once removed, there was no active bleeding noted.The patient was going to see the doctor for other pain management options.

• 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: 18844375
• Report Number: 3010676138-2024-00032
• Device Sequence Number: 18100914
• Product Code: GZF
• UDI-Device Identifier: 00850051034390
• UDI-Public: (01)00850051034390(17)250101(01)00850051034376(17)250401(21)2B17053-19
• Combination Product (Y/N): N
• 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): 03/05/2024

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: 01/01/2025
• Device Model Number: FR8A-TRL-B0, FR8A-TRL-A0
• Device Lot Number: SWO230116, SWO230410
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2022
• 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 Sex: Female