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

Model Number	PDBT-915-2K
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	05/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The unintended stimulation/new pain questionnaire was reviewed for potential causes of the reported issue.Based on this review, the patient having another non-curonix device implanted and migration have been ruled out as potential root causes.The transmitter assembly associated with the complaint was returned for investigation.Investigation of the device was unable to replicate the alleged issue.Although the investigation did not replicate the alleged issue, the investigation found the rf connector was damaged due to improper/inadequate design.The sma rf connector solder joints to the pcb were cracked, partially separating the connector from the pcb and triggering the "low power detect" and/or "antenna disconnect" alarms.Therefore, the device cannot deliver therapy.In addition, the investigation found a damaged component as l12 was broken.A potential cause could be dropping the device onto hard surface.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-2025-0004 for additional investigation details and risk assessment for broken l12.Refer to capa-2024-0020 for additional investigation details for the broken rf connector.
Event or Problem Description
The patient reported receiving zapping/shocking sensations from their transmitter assembly when they sit up or bend down.The patient was provided a loaner transmitter assembly and has been doing great.

• Brand Name: FREEDOM PERIPHERAL NERVE STIMULATOR
• Common Device Name: TRANSMITTER ASSEMBLY
• Manufacturer (Section D): CURONIX LLC; 1310 park central blvd s; pompano beach FL 33064
• Manufacturer (Section G): CURONIX LLC; 1310 park central blvd s; pompano beach FL 33064
• Manufacturer Contact: tena jimmerson ; 1310 park central boulevard s.; pompano beach, FL 33064 ; 8009655134
• MDR Report Key: 22331523
• Report Number: 3010676138-2025-00127
• Device Sequence Number: 9354910
• Product Code: GZF
• UDI-Device Identifier: 00850051034550
• UDI-Public: (01)00850051034550
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 06/25/2025

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: 01174-DT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2024
• 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 LN:SWO241003 SN: (B)(6)
• Patient Age: 59 YR
• Patient Sex: Female