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	Shock from Patient Lead(s) (3162)
Date of Event	09/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported a shocking sensation from one of their transmitter assemblies.The patient was provided a replacement transmitter assembly, the programs were changed, and they have not experienced additional shocking sensations.
Additional Manufacturer Narrative
The unintended stimulation/new pain questionnaire was reviewed for potential causes of the reported issue.The transmitter assembly associated with the complaint was returned for investigation.The investigation of the device was unable to replicate the alleged issue.After fully charging the battery, the unit operated for 18 hours and 52 minutes on the active setting at maximum power index.However, the investigation found a damaged component as l12 was broken.Although the investigation found a damaged component, the investigation of the device was unable to replicate the alleged issue.The stimulator is used to treat pain.The cause of the reported issue is attributed to two identified root causes: programming parameters as changing the programs on the transmitter assembly resolved the report of shocking sensations (user error-commercial team member).Damaged component as the investigation found l12 was broken (failure).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in unintended stimulation/new pain issues.Unintended stimulation/new pain issue rates remain acceptably low; thus, a capa is not required.Unintended stimulation/new pain issues rates will continue to be tracked and trended.Refer to issue- (b)(4) for additional investigation details and risk assessment for broken l12.

• 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: 23339525
• Report Number: 3010676138-2025-00231
• Device Sequence Number: 9452550
• Product Code: GZF
• UDI-Device Identifier: 00850051034550
• UDI-Public: (01)00850051034550
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 10/20/2025

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: 01064-DT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2025
• Initial Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NEUROSTIMULATOR SN: (B)(6), LN: SWO240216.
• Patient Age: 77 YR
• Patient Sex: Female