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	02/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The waa heat related failure questionnaire was reviewed for potential causes of the reported issue.Based on this review, the patient placed the device directly on the skin which is non-compliant to the ifu.Per the transmitter assembly instructions for use for freedom neurostimulation systems, 05-20915 rev.9, "transmitter assembly skin contact - the transmitter assembly and wearable accessories must not be placed directly on the skin.Direct skin contact may cause irritation and/or sensitivity to the materials.The transmitter assembly must always be placed over a thin layer of clothing or material." the transmitter assembly associated with the complaint was returned for investigation.Investigation of the device was unable to replicate the alleged issue, and no non-conformances were found.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: 29.2°c.Internal thermal temperature while charging: 29.8°c.Outside thermal temperature while operating: 29.3°c.Internal thermal temperature while operating: 32.2°c.The outside thermal temperature while charging was 29.2°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.The stimulator is used to treat pain.Although the reported issue was not replicated, non-compliance to the ifu was identified as the patient wore the device directly on the skin (user error-patient).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 their transmitter assembly was getting hot and caused a burning sensation to the skin.Topical ointment was used and as of (b)(6) 2026, the skin is healing.Additionally, the patient was provided a replacement transmitter assembly.The patient has a follow up appointment on (b)(6) 2026.No further information is available.

• 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: 24618692
• Report Number: 3010676138-2026-00045
• Device Sequence Number: 9575423
• Product Code: GZF
• UDI-Device Identifier: 00850051034550
• UDI-Public: (01)00850051034550
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K233162
• 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): 03/17/2026

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: 01452-DT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2026
• Initial Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2025
• 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: 88 YR
• Patient Sex: Male