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

Model Number	PDBT-915-2K
Medical Device Problem Codes	Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The transmitter assembly associated with the complaint was returned for investigation.Although the investigation did not replicate the alleged issue, 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.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: 32.9°c.Internal thermal temperature while charging: 42.4°c.Outside thermal temperature while operating: 29.1°c.Internal thermal temperature while operating: 31.3°c.The outside thermal temperature while charging was 32.9°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.Although the investigation did not replicate the alleged issue, the investigation found a broken connector (improper/inadequate design) as well as non-compliance to the ifu (user error-patient).Refer to capa: 2024-0020 for additional investigation details for the broken rf connector.Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in non-compliance to ifu.Non-compliance to ifu rates remain acceptably low; thus, capa is not required.Non-compliance to ifu rates will continue to be tracked and trended.
Event or Problem Description
The patient reported a burning sensation from their transmitter assembly.However, the burning sensation did not cause tissue damage or require medical intervention.The patient was provided a replacement transmitter assembly.

• 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: 23873290
• Report Number: 3010676138-2025-00292
• Device Sequence Number: 11900316
• Product Code: GZF
• UDI-Device Identifier: 00850051034550
• UDI-Public: (01)00850051034550
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/22/2025

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: 01475-DT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2025
• 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: 80 YR
• Patient Sex: Unknown