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

Model Number	PDBT-915-2K
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	03/31/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The transmitter assembly associated with the complaint was returned for investigation.Although the report of overheating was not replicated, the investigation found evidence of liquid ingress.The investigation found the unit board was damaged by liquid ingress and will not power on which was the cause of the complaint.The cause is attributed to pcb failure due to liquid damage.Attached to the rma report is a picture that shows the presence of liquid on the board.As a result of the liquid ingress (i.E.Efflorescence, oxidation), multiple circuits were damaged.Additionally, the investigation found a damaged component as l12 was broken.A potential cause could be dropping the device onto hard surface.For the report of overheating: thermal imaging was used to verify the outside temperature of the device while charging, the internal temperature of the device while charging, the outside temperature of the device while operating, and the internal temperature of the device while operating.Results are as follows: outside thermal temperature while charging: 33.7°c.Internal thermal temperature while charging: 40.1°c.Outside thermal temperature while operating: 29.6°c.Internal thermal temperature while operating: 33.2°c.The outside thermal temperature while charging was 33.7°c, which is below the product requirements specification of 41°c (106°f).Based on the thermal imaging, there is no evidence of thermal damage and the product met temperature specifications.Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in liquid ingress.Liquid ingress rates remain acceptably low; thus, capa is not required.Liquid ingress rates will continue to be tracked and trended.Refer to issue-2025-0004 for additional investigation details and risk assessment for broken l12.
Event or Problem Description
The patient reportedly felt a burning sensation on their back while wearing the transmitter assembly.Additionally, the patient reported their transmitter assembly and cord were both hot.The patient did not require medical intervention and was provided a replacement transmitter assembly.No further issues have been reported.

• 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: 21859664
• Report Number: 3010676138-2025-00083
• Device Sequence Number: 4695850
• Product Code: GZF
• UDI-Device Identifier: 00850051034550
• UDI-Public: (01)00850051034550
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 04/17/2025

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: 01036-DT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2024
• 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: 38 YR
• Patient Sex: Male