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

Model Number	PDBT-915-2K
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Power Problem (3010)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	03/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The transmitter assembly associated with the complaint was returned for investigation.The investigation found the rf connector was damaged due to improper/inadequate design.The sma rf connector solder joints to the pcb were cracked, partially separating the connector from the pcb and triggering the "low power detect" and/or "antenna disconnect" alarms.Therefore, the device cannot deliver therapy.Additionally, the investigation found the power amplifier was damaged (failure mode is low impedance on all three terminals), triggering the "low power detect" alarm and causing the battery to deplete in a short amount of time.Due to the damaged rf connector and power amplifier, the device does not operate and thermal imaging of the device while operating could not be obtained.For the report of overheating: thermal imaging was used to verify the outside and internal temperature of the device while charging.Results are as follows: outside thermal temperature while charging: 39.8°c.Internal thermal temperature while charging: 57.9°c.The outside thermal temperature while charging was 39.8°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.Refer to capa-2024-0020 for additional investigation details the for broken rf connector.Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in blown power amplifier.Blown power amplifier rates remain acceptably low; thus, capa is not required.Blown power amplifier rates will continue to be tracked and trended.
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.

• 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: 21691056
• Report Number: 3010676138-2025-00066
• Device Sequence Number: 18336412
• Product Code: GZF
• UDI-Device Identifier: 00818225020150
• UDI-Public: (01)00818225020150
• Combination Product (Y/N): N
• 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): 03/25/2025

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: 00610-ST
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2025
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2022
• 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
• Patient Age: 55 YR
• Patient Sex: Female