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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The patient reported the transmitter assembly emitted a burning smell and got extremely hot while charging.However, the overheating did not cause a burning sensation to the skin or tissue damage and the patient did not require medical intervention.The patient also reported the device would no longer charge.The patient was provided a replacement transmitter assembly.
Additional Manufacturer Narrative
The waa heat related failure questionnaire was reviewed for potential causes of the reported issue.The patient wearing the device directly on the skin has been ruled out as a potential root cause.However, the patient was not using the usb charger and cable provided to recharge the transmitter assembly.Per transmitter assembly instructions for use for freedom neurostimulation systems, 05-20915 rev.9, "use only the usb charger and cable provided to recharge the transmitter." the transmitter assembly associated with the complaint was returned for investigation.The investigation found burned components including: d19, u2, u20, u24.Due to the damaged components, the device will not operate and thermal imaging of the device could not be performed.In addition, the investigation found a damaged component as l12 was broken.The stimulator is used to treat pain.The cause of reported issue is due to non-compliance to the ifu as the patient was not using the usb charger and cable provided to recharge the transmitter assembly (user error-patient).Refer to capa-2024-0020 for additional investigation details for the damaged component l12.Refer to issue-(b)(4) for additional investigation details and risk assessment for the incorrect charger being used causing burning pcb components.

• 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: 25166910
• Report Number: 3010676138-2026-00079
• Device Sequence Number: 10566458
• Product Code: GZF
• UDI-Device Identifier: 00850051034550
• UDI-Public: (01)00850051034550
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 05/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: PDBT-915-2K
• Device Lot Number: 01610-DT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2026
• 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: 88 YR
• Patient Sex: Unknown