MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR; TRANSMITTER ASSEMBLY

Model Number	PDBT-915-2K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	05/30/2025
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, the incorrect questionnaire was completed.Implanting the device off-label, migration, and no attempts to change the programs on the transmitter assembly have been ruled out.The device was not returned and could not be analyzed by engineering.Attempts to recover the device were unsuccessful, preventing engineering from performing investigation.The root cause of the event could not be determined, and the alleged issue could not be confirmed.This complaint will be closed with no further action.Complaints are tracked and trended as part of management review.The stimulator is used to treat pain.The cause of the reported issue is unknown.The investigation findings do not lead to a clear conclusion about the cause of the reported issue.Therefore, conclusion has been selected as unable to determine root cause.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 a burning sensation in their foot when turning the device on.Several attempts have been made to change the programs on the transmitter assembly with no change as the patient is still experiencing a burning sensation within 10-20 minutes of having the device turned on with lowest settings possible.Additionally, the patient reported a discoloration on their ankle close to the device.However, it has resolved.As of june 16, 2025, the patient reported the sensations have slowly gone away after having the device turned off for a few days.

• Brand Name: FREEDOM PERIPHERAL NERVE STIMULATOR
• Common Device Name: TRANSMITTER ASSEMBLY
• 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: 22331597
• Report Number: 3010676138-2025-00128
• Device Sequence Number: 9436710
• Product Code: GZF
• UDI-Device Identifier: 00850051034550
• UDI-Public: (01)00850051034550
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K171366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/25/2025

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 Model Number: PDBT-915-2K
• Device Lot Number: 01313-DT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NEUROSTIMULATOR LN: SWO250115 SN: (B)(6)
• Patient Age: 57 YR
• Patient Sex: Female