MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	STQ4-SPR-B0
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Erosion (1750); Skin Infection (4544); Swelling/ Edema (4577)
Date of Event	01/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device in an off-label location, not performing an x-ray immediately after the implant procedure to confirm device placement, inadequate fixation, implanting a damaged neurostimulator, implanting the device 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 patient has lost a significant amount of weight which has reduced their subcutaneous fatty tissue, making the coil more visible and they have circulation issues in their calf.Additionally, the device was implanted at a 90° angle and tunneled horizontally which is non-compliant to the ifu.Per the freedom peripheral nerve stimulator system implantation of neurostimulator instructions for use, 05-20200 rev.6, includes the following statement: "the electrode array should be implanted straight for optimal performance and must be internalized from the proximal tip to the distal end of the electrode array." 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 cause of the reported issue is attributed to two identified root causes: non-compliance to the ifu as the device was implanted at a 90° angle and tunneled horizontally (user error-clinician).Patient is a poor candidate due to age, weight, or mental capacity as they have circulation issues in their calf and lost a significant amount of weight (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.
Event or Problem Description
The patient reported erosion, redness, minor swelling, and a possible infection at the incision site.During the patient's follow-up appointment on (b)(6) 2025, an infection was not present, erosion was not confirmed, antibiotics were not prescribed, and intervention was not necessary.The redness is gone, the patient is receiving great pain relief and is being very active.

• 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: 21337064
• Report Number: 3010676138-2025-00024
• Device Sequence Number: 3849511
• Product Code: GZF
• UDI-Device Identifier: 00818225020495
• UDI-Public: (01)00818225020495(17)240301
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K171366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 02/07/2025

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: 03/01/2024
• Device Model Number: STQ4-SPR-B0
• Device Lot Number: SWO220322
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/28/2022
• 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
• Patient Age: 70 YR
• Patient Sex: Male