MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	FR4A-TRL-A0
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	02/19/2024
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 problem occurring before implanting the device, using the transmitter during the incident, implanting the device at an off-label location, implanting the device too close to the targeted nerve, migration, and puncturing bone or tissue inadvertently during the procedure have been ruled out as potential cause.However, the patient has a preexisting cardiac history and has had two previous heart attacks.Additionally, the patient held their plavix medication even though the office did not tell them to do so.The stimulator is used to treat pain.The cause of the reported issue is contributed to two identified root causes as follows: -the patient is a poor candidate due to health, weight, age, or mental capacity as they have a history of heart attacks (user error - clinician).-patient non-compliance as the patient held their plavix medication (user error - patient).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 had a heart attack on the or table after the trial procedure was complete.The patient was given nitroglycerin, was monitored, and an ambulance was called due to continued chest pain, left arm pain, and nausea.The patient was kept over night in the hospital and a cardiac catheterization was done.They are using the device, getting great relief in their knee, and are doing well and are at home.The patient is planning to move forward with a permanent implant procedure after getting significant relief of knee pain during trial.They will follow up with their cardiologist to get clearance before the permanent implant procedure.

• 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: 18917674
• Report Number: 3010676138-2024-00035
• Device Sequence Number: 6769932
• Product Code: GZF
• UDI-Device Identifier: 00850051034369
• UDI-Public: (01)00850051034369(17)250101
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K171366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 03/15/2024

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: 01/01/2025
• Device Model Number: FR4A-TRL-A0
• Device Lot Number: SWO230116
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Initial Report FDA Received Date: 03/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2022
• 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: Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female