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	Fever (1858); Hemorrhage/Blood Loss/Bleeding (1888); Urinary Tract Infection (2120)
Date of Event	04/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported some bleeding, lack of therapy, and a fever and was instructed to go to the emergency department.X-rays were performed which confirmed migration.Additional testing revealed the patient had an existing uti, causing the fever.The emergency department physician pulled the trial neurostimulators on (b)(6) 2024 and the patient is now healthy.However, the patient will not be moving forward with a permanent implant procedure.
Additional Manufacturer Narrative
The 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 achieving paresthesia on the table, and not performing an x-ray immediately after the procedure to confirm placement have been ruled out as potential causes.Additionally, severe force applied to the implant, excessive twisting, bending, or stretching, and not implanting the device according to the ifu were ruled out as potential causes.However, the patient had an unknown urinary incontinence problem, causing them to have utis frequently.The fever was due to the uti and is unrelated to the curonix device.In addition, the patient seemed to have issues with the adhesive sticking to the skin, causing the tegaderm to come loose and allowing the neurostimulators to migrate.A curonix representative conducted a review of sterilization and packaging records for the respective product lot; curonix has confirmed that the product was delivered sterile, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.The stimulator is used to treat pain.The cause of the reported issues are unrelated to the curonix device as the fever was a result of a uti and the bleeding and lack of therapy was caused by the tegaderm coming loose and allowing the trial neurostimulators to migrate (no fault found).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 at this time.Loss of therapy/no therapy issue rates will continue to be tracked and trended.

• 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: 19262311
• Report Number: 3010676138-2024-00071
• Device Sequence Number: 6493291
• Product Code: GZF
• UDI-Device Identifier: 00850051034376
• UDI-Public: (01)00850051034376(17)251201(01)00850051034390(17)251201(21)2B17256-75
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 05/07/2024

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: 12/01/2025
• Device Model Number: FR8A-TRL-A0, FR8A-TRL-B0
• Device Lot Number: SWO231207, SWO231207
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2024
• Initial Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/23/2022
• 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: Male