MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	FR4A-TRL-B0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	10/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The other adverse events issues questionnaire was reviewed for potential causes of the reported issue.Based on this review, the incident occurring before the implant of the device and implanting the device at an off-label location have been ruled out as potential causes.The reaction was caused by the adhesive used to secure the lead as the patient has sensitive skin.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 provided information does not evidence that the curonix device contributed to the issue and the reaction is unrelated to the curonix device (no fault found).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in other adverse events issues.Other adverse events issues rates remain acceptably low; thus, capa is not required.Other adverse events issues rates will continue to be tracked and trended.
Event or Problem Description
The patient reported itchiness, irritation, and redness from the tape used to secure the trial lead.The trial lead pull was performed on (b)(6) 2023 and the patient will not be moving forward with a permanent implant.The commercial team member attempted to contact the patient to obtain additional information.However, the attempts were unsuccessful.No additional information provided.

• Brand Name: FREEDOM PERIPHERAL NERVE STIMULATOR
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• Manufacturer (Section D): CURONIX LLC; 1310 park central boulevard s.; pompano beach FL 33064
• Manufacturer (Section G): CURONIX LLC; 1310 park central boulevard s.; pompano beach FL 33064
• Manufacturer Contact: alicia pagliaro ; 1310 park central boulevard s.; pompano beach, FL 33064 ; 8009655134
• MDR Report Key: 18049480
• Report Number: 3010676138-2023-00223
• Device Sequence Number: 7427393
• Product Code: GZF
• UDI-Device Identifier: 00850051034383
• UDI-Public: (01)00850051034383(17)241001
• 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: 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): 11/01/2023

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: 10/01/2024
• Device Model Number: FR4A-TRL-B0
• Device Lot Number: SWO221025
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2023
• Initial Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2022
• 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 Sex: Female