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	09/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The loss of therapy/no therapy questionnaire was reviewed for potential causes of the reported issue.Based on this review, not achieving paresthesia on the table, not performing an x-ray immediately after the procedure to confirm placement, and inadequate fixation have been ruled out as potential causes.Additionally, the patient having contraindicating conditions and no attempts to reprogram the transmitter have been ruled out.However, the device was implanted at the occipital nerve which is off-label use.Per the freedom peripheral nerve stimulator system implantation of neurostimulator instructions for use, 05-20200 rev.6 "the freedom pns system is not intended to treat pain in the craniofacial region".The stimulator is used to treat pain.Although the cause of the "pop" sensation is unknown, the device was implanted at the occipital nerve which is off-label use (user error-clinician).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in loss of therapy/no therapy issues.Loss of therapy/no therapy issue rates remain acceptably low; thus, a capa is not required at this time.Loss of therapy/no therapy issue rates will continue to be tracked and trended.
Event or Problem Description
The patient reportedly felt a "pop" sensation and has since experienced pain and loss of therapy.The transmitter settings were changed and although the patient is still in some pain, the pain has reduced.The patient will follow-up with the implanting clinician for next steps and they are awaiting approval from their cardiologist for an explant 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: 20356195
• Report Number: 3010676138-2024-00199
• Device Sequence Number: 7208868
• Product Code: GZF
• UDI-Device Identifier: 00818225020495
• UDI-Public: (01)00818225020495(17)230401
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 10/02/2024

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: 04/01/2023
• Device Model Number: STQ4-SPR-B0
• Device Lot Number: SWO210422
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/30/2021
• 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 Age: 60 YR
• Patient Sex: Male