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

Model Number	PDBT-915-2K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Rash (2033); Skin Burning Sensation (4540)
Date of Event	03/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported redness and a rash on their skin under where the transmitter assembly is worn.Additionally, the patient reported warmth from the transmitter assembly which caused a burning sensation to the skin.However, the burning sensation did not cause tissue damage or require medical intervention.As of (b)(6) 2026, the rash has resolved completely, the patient was provided a replacement transmitter assembly, and the patient is doing well.
Additional Manufacturer Narrative
The waa heat related failure questionnaire was reviewed for potential causes of the reported issue.Based on this review, the patient wearing the transmitter assembly directly on the skin has been ruled out as a potential root cause.The transmitter 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: 30.6°c, internal thermal temperature while charging: 29.8°c, outside thermal temperature while operating: 30.1°c, internal thermal temperature while operating: 31.8°c.The outside thermal temperature while charging was 30.6°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 no problem found.No problem found rates remain acceptably low; thus, capa is not required.No problem found rates will continue to be tracked and trended.

• 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: 24794177
• Report Number: 3010676138-2026-00056
• Device Sequence Number: 8646626
• Product Code: GZF
• UDI-Device Identifier: 00850051034550
• UDI-Public: (01)00850051034550
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/06/2026

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: 01572-DT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2026
• 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: 67 YR
• Patient Sex: Female