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	11/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported their transmitter assembly gets hot and caused a burning sensation to the skin.However, the overheating did not cause tissue damage or require medical intervention.
Additional Manufacturer Narrative
The waa heat related failure questionnaire was reviewed for potential causes of the reported issue.The patient wearing the device directly on the skin has been ruled out as a potential root cause.Potential causes of the transmitter overheating are blown power amplifier, continuous stimulation, charger/cable short, misuse of the cable (forced entry of the usb charger cord into the transmitter), pcb short, battery short, battery excessive current (into or out of battery), thermal cutoff not working (70 deg c), and supplier manufacturing issue.The transmitter assembly associated with the complaint was requested for investigation.However, it has not yet been received.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.Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in product not returned rates.Product not returned rates remain acceptably low; thus, capa is not required.Product not returned rates will continue to be tracked and trended.

• Brand Name: FREEDOM PERIPHERAL NERVE STIMULATOR
• Common Device Name: TRANSMITTER ASSEMBLY
• Manufacturer (Section D): CURONIX LLC; 1310 park central boulevard s.; pompano beach FL 33064
• Manufacturer (Section G): CURONIX LLC; 1310 park central boulevard s.; pompano beach FL 33064
• Manufacturer Contact: alicia pagliaro ; 1310 park central boulevard s.; pompano beach, FL 33064 ; 8009655134
• MDR Report Key: 23790567
• Report Number: 3010676138-2025-00281
• Device Sequence Number: 21451874
• Product Code: GZF
• UDI-Device Identifier: 00850051034550
• UDI-Public: (01)00850051034550
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/12/2025

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: 01357-DT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/29/2025
• 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
• Patient Age: 65 YR
• Patient Sex: Female