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

Model Number	PDBT-915-2K
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The transmitter assembly associated with the complaint was returned for investigation.The investigation found the unit board was damaged by liquid ingress and will not power on which was the cause of the complaint.The cause is attributed to pcb failure due to liquid damage.As a result of the liquid ingress (i.E.Efflorescence, oxidation), multiple circuits were damaged.Attached to the rma report is a picture that shows the presence of liquid on the board.In addition, as a result of the liquid ingress, u23 shorted which caused excessive current through fb1 causing it to burn.Although u23 showed signs of burning, there was no adverse patient impact and the patient did not report any overheating or burning sensation to the skin while using the transmitter assembly.Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in liquid ingress.Liquid ingress rates remain acceptably low; thus, capa is not required.Liquid ingress rates will continue to be tracked and trended.Refer to issue (b)(4) for additional investigations and risk assessment for the burned component.
Event or Problem Description
The patient reported their transmitter assembly would not charge despite using the usb charger and cable provided to recharge the transmitter.The patient was provided a replacement transmitter assembly and no further issues have been reported.

• 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: 25323354
• Report Number: 3010676138-2026-00092
• Device Sequence Number: 5318433
• Product Code: GZF
• UDI-Device Identifier: 00850051034550
• UDI-Public: (01)00850051034550
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 05/28/2026

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: 01476-DT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2025
• 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: 79 YR
• Patient Sex: Unknown