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 Codes	Burning Sensation (2146); Blister (4537)
Date of Event	02/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The waa heat related failure questionnaire was reviewed for potential causes of the reported issue.The wearable was placed directly on the skin which is non-complaint to the ifu.Per curonix pns wearable quick reference card, (b)(4), "product is to be worn over a thin layer of clothing at all times.Do not place directly on skin." the device was not returned and could not be analyzed by engineering.Attempts to recover the device were unsuccessful, preventing engineering from performing investigation.This complaint will be closed with no further action.Complaints are tracked and trended as part of management review.The stimulator is used to treat pain.Although the cause of the burning sensation and blister is unknown, non-compliance to the ifu was identified as the wearable was placed directly on the skin (user error-patient).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in waa heat related failure.Waa heat related failure rates remain acceptably low; thus, a capa is not required at this time.Waa heat related failure rates will continue to be tracked and trended.
Event or Problem Description
The patient reported a burning sensation and a blister on their skin underneath their transmitter assembly.The patient has been using their other transmitter assembly and is now wearing the wearable over a sock.As of (b)(6) 2026, the blister has cleared up and the patient has not experienced any additional burning sensations.

• 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: 24403208
• Report Number: 3010676138-2026-00030
• Device Sequence Number: 21308420
• Product Code: GZF
• UDI-Device Identifier: 00850051034550
• UDI-Public: (01)00850051034550
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/20/2026

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: 01475-DT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 46 YR
• Patient Sex: Male