MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	STQ4-SPR-B0
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The unintended stimulation/new pain questionnaire was reviewed for potential causes of the reported issue.Based on this review, the questionnaire was completed by quality with limited information.However, the device was implanted at an off-label location as it was implanted in the patient's forehead.Per freedom pns neurostimulator instructions for use, 05-20200, "the freedom pns system is not intended to treat pain in the craniofacial region." the stimulator is used to treat pain.The cause of the reported issue is due to off-label use as the device was implanted in the patient's forehead (user error - clinician).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in unintended stimulation/new pain issues.Unintended stimulation/new pain issue rates remain acceptably low; thus, a capa is not required.Unintended stimulation/new pain issue rates will continue to be tracked and trended.
Event or Problem Description
The patient reported major head pain for three days despite using the device regularly and taking two heavy pain medicines.Additionally, the patient reported potential migration as the patient was implanted in the forehead and feels the neurostimulator above the eyebrow.No further information is available at this time.There have been multiple attempts to contact the patient with no success.

• 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: 19304319
• Report Number: 3010676138-2024-00085
• Device Sequence Number: 20465460
• Product Code: GZF
• UDI-Device Identifier: 00818225020495
• UDI-Public: (01)00818225020495(17)220901
• 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: 2021
• 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): 05/13/2024

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: 09/01/2022
• Device Model Number: STQ4-SPR-B0
• Device Lot Number: SWO200929
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2024
• Initial Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2020
• 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