MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	STQ4-RCV-B0
Medical Device Problem Codes	Use of Device Problem (1670); Migration (4003)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	02/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported their neurostimulator has migrated close to the surface of the skin which causes sensitivity and irritation from rubbing on socks and shoes.Additionally, the patient reported uncomfortable stimulation and they have not worn the device for over six months.The patient has moved to another state and has established care with a practice that is willing to do an explant or a revision procedure.However, the procedure has not yet been approved or scheduled.
Additional Manufacturer Narrative
The loss of therapy/no therapy questionnaire was reviewed for potential causes of the reported issue.Based on this review, never achieving therapy, implanting the device off-label, and not achieving paresthesia on the table have been ruled out as potential causes.However, migration was confirmed via x-ray.The patient has reportedly experienced falls and surgeries since their implant procedure which may have caused migration.The stimulator is used to treat pain.The cause of the uncomfortable stimulation and irritation is due to migration.However, the cause of migration is due to severe force applied to the implant (patient fall, accident) as the patient has experienced falls and surgeries since their implant procedure (user error-patient).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in loss of therapy/no therapy.Loss of therapy/no therapy rates remain acceptably low; thus, a capa is not required at this time.Loss of therapy/no therapy rates will continue to be tracked and trended.
Additional Manufacturer Narrative
The loss of therapy/no therapy questionnaire was reviewed for potential causes of the reported issue.Based on this review, never achieving therapy, implanting the device off-label, and not achieving paresthesia on the table have been ruled out as potential causes.However, migration was confirmed via x-ray.The patient has reportedly experienced falls and surgeries since their implant procedure which may have caused migration.The stimulator is used to treat pain.The cause of the uncomfortable stimulation and irritation is due to migration.However, the cause of migration is due to severe force applied to the implant (patient fall, accident) as the patient has experienced falls and surgeries since their implant procedure (user error-patient).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in loss of therapy/no therapy.Loss of therapy/no therapy rates remain acceptably low; thus, a capa is not required at this time.Loss of therapy/no therapy rates will continue to be tracked and trended.
Event or Problem Description
The patient reported their neurostimulator has migrated close to the surface of the skin which causes sensitivity and irritation from rubbing on socks and shoes.Additionally, the patient reported uncomfortable stimulation and they have not worn the device for over six months.The patient has moved to another state and has established care with a practice that is willing to do an explant or a revision procedure.However, the procedure has not yet been approved or scheduled.Additional information was received on may 12, 2025.An explant procedure was successfully performed on (b)(6) 2025 and the surgery went as expected.No further issues have been reported.

• 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: 21542663
• Report Number: 3010676138-2025-00047
• Device Sequence Number: 15215503
• Product Code: GZF
• UDI-Device Identifier: 00818225020495
• UDI-Public: (01)00818225020495(17)240201
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2025

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: 02/01/2024
• Device Model Number: STQ4-RCV-B0
• Device Lot Number: SWO220428
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2022
• 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: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female