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	Electric Shock (2554)
Date of Event	10/11/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported they have not had pain relief since the device was implanted.Additionally, the patient reported they have not used the device for an extended amount of time due to potential overstimulation.The commercial team member confirmed all components seemed to be working properly and the programs on the transmitter assembly were changed.The patient was encouraged to try the new settings and follow-up with any issues.As of (b)(6) 2025, the patient is utilizing therapy and has not had any further complaints since resuming therapy.
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 has been ruled out as a potential cause.Additionally, migration was ruled out.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.The cause is attributed to pcb failure due to liquid damage.Attached to the rma report is a picture that shows the presence of liquid on the board.As a result of the liquid ingress (i.E.Efflorescence, oxidation), multiple circuits were damaged.The stimulator is used to treat pain.The cause of the overstimulation is due to programming parameters as the issue was resolved after the programs on the transmitter assembly were changed (user error-clinical representative).Although liquid ingress was observed during the investigation of the returned transmitter assembly, this did not contribute to the report of overstimulation.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.

• 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: 21687734
• Report Number: 3010676138-2025-00068
• Device Sequence Number: 9059296
• Product Code: GZF
• UDI-Device Identifier: 00818225020150
• UDI-Public: (01)00818225020150
• Combination Product (Y/N): N
• 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): 03/25/2025

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: 00705-DT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2022
• 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:SWO230807 SN: (B)(6)
• Patient Age: 65 YR
• Patient Sex: Female