MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	STQ4-SPR-B0, STQ4-RCV-A0
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Blister (4537)
Date of Event	09/29/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported they stopped using the device due to redness and blistering at the surgical site.Antibiotics were prescribed and an explant procedure is tentatively scheduled for (b)(6) 2024.Although the patient did not have any redness or blistering at their last follow up, they would like the device explanted to avoid another "flare up" since they cannot tolerate anything over their skin.
Additional Manufacturer Narrative
The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the device at an off-label location, not performing x-rays immediately after the procedure to confirm device placement, not implanting the device per ifu, implanting a damaged stimulator, the patient going through an mri procedure, implanting the stimulator after the expiration date, not preparing the skin with an antiseptic solution, and the patient not attending the post-op visit have been ruled out as potential causes.However, the patient has diabetes which their physician believes contributed to their issues.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 due the patient being a poor candidate due to health, weight, age, or mental capacity as they have diabetes (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, capa is not required. 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 blvd s; pompano beach, FL 33064
• MDR Report Key: 18535809
• Report Number: 3010676138-2024-00002
• Device Sequence Number: 6732174
• Product Code: GZF
• UDI-Device Identifier: 00818225020495
• UDI-Public: (01)00818225020495(17)240301(01)00818225020464(17)240301(21)2B14802-19
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 01/17/2024

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: 03/01/2024
• Device Model Number: STQ4-SPR-B0, STQ4-RCV-A0
• Device Lot Number: SWO220322, SWO220322
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2023
• Initial Report FDA Received Date: 01/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Unknown