MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	STQ4-SPR-B0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abscess (1690)
Date of Event	09/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported they saw a dermatologist in (b)(6) due to an abscess that was growing in their receiver incision.On (b)(6) 2024, the dermatologist opened the receiver pocket, exposed the neurostimulator, and drained and removed the abscess.A culture and sample of the abscess were taken and antibiotics were prescribed.However, there were no signs of infection present and the abscess was benign.On (b)(6) 2024 the patient had a follow-up appointment for an incision check.The incision looked red, swollen, painful, and warm.The dermatologist prescribed another round of antibiotics and instructed the patient to follow-up with their implanting clinician.During their appointment on (b)(6) 2024, another abscess/lesion was forming.An explant procedure was performed on (b)(6) 2024 and the patient is healing well.
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 procedure to confirm placement, inadequate fixation, implanting a damaged neurostimulator, implanting the neurostimulator after the expiration date, not prepping the skin with an antiseptic solution, not irrigating the incision site with an antibiotic solution before closure, improperly closing the surgical site, multiple tunneling attempts, using inappropriate tools, and not prescribing antibiotics pre-operatively have been ruled out as potential causes.Additionally, migration, the patient picking or touching the wound, the patient having contraindicating conditions, severe force applied to the implant, and excessive twisting, bending, or stretching have been ruled out.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 issue is unknown.The investigation findings do not lead to a clear conclusion about the cause of the reported issue.Therefore, the conclusion has been selected as unable to determine the root cause.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: 20644420
• Report Number: 3010676138-2024-00235
• Device Sequence Number: 7367321
• Product Code: GZF
• UDI-Device Identifier: 00818225020495
• UDI-Public: (01)00818225020495(17)211001
• 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: 2020
• 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): 11/08/2024

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: 10/01/2021
• Device Model Number: STQ4-SPR-B0
• Device Lot Number: SWO191002
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2019
• 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