MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	FR4A-TRL-A0
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	10/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was scheduled for a neurostimulator pull on (b)(6) 2024.During the procedure, the occipital neurostimulator was pulling which caused the incision to become red, itchy, and irritated.Antibiotics were prescribed and a bandage was placed on the incision.
Additional Manufacturer Narrative
The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the neurostimulator after the expiration date, not prepping the skin with an antiseptic solution, improperly closing the surgical site, multiple tunneling attempts and using inappropriate tools have been ruled out as potential causes.However, the device was implanted in an off-label location as it was implanted at the occipital nerve.Per the freedom peripheral nerve stimulator system implantation of neurostimulator instructions for use, 05-20200 rev 6, "the freedom pns system is not intended to treat pain in the craniofacial region".The stimulator is used to treat pain.The cause of the reported issue is due to off-label use as the device was implanted in the craniofacial region at the occipital nerve (user error- clinician).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in surgical issues.Surgical issue rates remain acceptably low; thus, a capa is not required at this time.Surgical 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: 20739816
• Report Number: 3010676138-2024-00246
• Device Sequence Number: 8613417
• Product Code: GZF
• UDI-Device Identifier: 00850051034369
• UDI-Public: (01)00850051034369(17)260301
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 11/20/2024

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: 03/01/2026
• Device Model Number: FR4A-TRL-A0
• Device Lot Number: SWO240308
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/13/2023
• 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: 65 YR
• Patient Sex: Female