MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	FR8A-TRL-A0, FR8A-TRL-B0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Pain (1994)
Date of Event	02/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The other adverse events questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device in an off label location, implanting the device too close to the targeted nerve, and inadvertently puncturing the bone or tissue have been ruled out.Additionally, the introducer from the kit was used and the patient did not report a fall or severe force applied to or near the incision site.The cause of the tissue trauma is unknown.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, conclusion 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 other adverse events issues.Other adverse events issues rates remain acceptably low; thus, a capa is not required.Other adverse events issues rates will continue to be tracked and trended.
Event or Problem Description
The patient reported post-operation soreness, bruising, and pain.Precautionary antibiotics were prescribed and the lead was pulled early on february 20, 2024.The provider reported low suspicion of infection but endorsed bruising and tissue trauma in the area.Post lead pull, the patient is still sore but is continuing to feel better, and their pain is back to baseline.Additionally, the patient is electing to move toward a permanent implant and is in the process of getting scheduled for a pre-operative visit with the implanting clinician.

• 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: 18917712
• Report Number: 3010676138-2024-00036
• Device Sequence Number: 6971003
• Product Code: GZF
• UDI-Device Identifier: 00850051034376
• UDI-Public: (01)00850051034376(17)250901(01)00850051034390(17)250101(21)2B17054-10
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/15/2024

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: 09/01/2025
• Device Model Number: FR8A-TRL-A0, FR8A-TRL-B0
• Device Lot Number: SWO210520, SWO210629
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female