MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	STQ4-RCV-A0, STQ4-SPR-B0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	01/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The other adverse events issues questionnaire was submitted by quality with limited information.There are no potential causes of stroke as stroke has never been attributed to the device in previous complaint investigations.The stimulator is used to treat pain.The cause of the stroke is unknown.The investigation findings do not lead to a clear conclusion about the cause of the reported issue.Therefore, conclusion has been selected as unable to determine root cause.Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in other adverse events issues.Other adverse events issue rates remain acceptably low; thus, a capa is not required at this time.Other adverse events issue rates will continue to be tracked and trended.
Event or Problem Description
On (b)(6) 2025 the patient experienced a stroke which was confirmed via mri.The patient is experiencing weakness on their right side as well as some speech issues.As of (b)(6) 2025, the patient is in rehab and getting stronger.

• 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: 21370698
• Report Number: 3010676138-2025-00026
• Device Sequence Number: 8482404
• Product Code: GZF
• UDI-Device Identifier: 00818225020464
• UDI-Public: (01)00818225020464(17)200801(01)00818225020495(17)200701(21)208946-46
• 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: 2019
• 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): 02/12/2025

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: 08/01/2020
• Device Model Number: STQ4-RCV-A0, STQ4-SPR-B0
• Device Lot Number: SWO180808, SWO180720
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2025
• Initial Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2018
• 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: Male