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

Model Number	PDBT-915-2K
Medical Device Problem Codes	Circuit Failure (1089); Moisture Damage (1405); Defective Component (2292)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	11/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported their transmitter assembly was overheating and caused a burning sensation to the skin.However, the patient did not experience any damage to the skin or require medical intervention.The patient turned off the device and stopped using it.
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.The transmitter assembly associated with the complaint was returned for investigation.The investigation found component failure as u11 failed.The boost regulator (dc-dc converter), output pin 4 and input pin 3 shorted to ground.As a result, excessive current draw was confirmed, causing heating of u11.The investigation also found the unit board was damaged by liquid ingress and will not power on.The cause is attributed to pcb failure due to liquid damage.As a result of the liquid ingress (i.E.Efflorescence, oxidation), multiple circuits were damaged.Attached to the rma report is a picture that shows the presence of liquid on the board.Additionally, the investigation found a damaged component as l12 was broken.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: 38.2°c.Internal thermal temperature while charging: 48.8°c.Outside thermal temperature while operating: 45.4°c.Internal thermal temperature while operating: 74.1°c.The outside thermal temperature while charging was 38.2°c, which is below the product requirements specification of 41°c (106°f).Retesting of thermal imaging was performed to further investigate the elevated internal thermal temperature while operating (74.1°c).Repeat testing results are as follows: outside thermal temperature while charging: 38.1°c.Internal thermal temperature while charging: 62.6°c.Outside thermal temperature while operating: 43.9°c.Internal thermal temperature while operating: 92.4°c.Due to the intermittent internal temperature fluctuation of the device while operating, issue-2025-0026 was opened.Refer to issue-2025-0026 for additional investigation details and risk assessment.Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in component failure or liquid ingress rates.Component failure and liquid ingress rates remain acceptably low; thus, capa is not required.Component failure and 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.Refer to issue-2025-0026 for additional investigation details and risk assessment for the internal thermal temperature while operating being elevated.

• 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: 23712191
• Report Number: 3010676138-2025-00276
• Device Sequence Number: 10401509
• 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): 12/03/2025

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: 01502-DT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 12/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2025
• 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: 82 YR
• Patient Sex: Unknown