MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	STQ4-RCV-A0, STQ4-SPR-B0
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Codes	Hearing Impairment (1881); Pain (1994); Vertigo (2134)
Date of Event	09/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The unintended stimulation/new pain questionnaire was reviewed for potential causes of the reported issue.It was noted the patient has another non-curonix scs device implanted and the patient has had several unrelated brain surgeries.Additionally, the device was implanted in an off-label location as it was implanted at the occipital nerve.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.The cause of the reported issue is due to off-label use as the device was implanted in the craniofacial region at the occipital nerve (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 issues rates will continue to be tracked and trended.
Event or Problem Description
The patient reported pain behind the eyes, forehead, ears, base of the skull, and neck as well as tunnel hearing and worsening vertigo.Additionally, the patient reported pressure like its going to pop.The patient also reported inadequate pain relief from the device since it was implanted and they have not worn their device since 2022.An explant procedure will be performed.However, a date has not been scheduled.No further information is available at this time.

• 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: 20477137
• Report Number: 3010676138-2024-00216
• Device Sequence Number: 12828756
• Product Code: GZF
• UDI-Device Identifier: 00818225020464
• UDI-Public: (01)00818225020464(17)220601(01)00818225020495(17)220301(21)2B11672-22
• 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: 2020
• 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): 10/17/2024

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: 06/01/2022
• Device Model Number: STQ4-RCV-A0, STQ4-SPR-B0
• Device Lot Number: SWO200604, SWO200329
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2020
• 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 Age: 43 YR
• Patient Sex: Male