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	06/30/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported one of their transmitter assemblies gives them a breakthrough paresthesia sensation.Two different antennas were used.However, the patient experienced the same sensation.As of (b)(6) 2025, the patient has been using their other transmitter assembly which has resolved the reported issue.Additionally, the patient was provided a new transmitter assembly which they will soon begin to use.
Additional Manufacturer Narrative
The unintended stimulation/new pain questionnaire was reviewed for potential causes of the reported issue.Based on this review, the questionnaire was completed with limited information.Potential causes of the reported issue include programming parameters, migration, interference from a non-curonix device, the patient being a poor candidate due to health, weight, age, or mental capacity, severe force applied to the implant, and off-label use.The transmitter associated with the complaint was returned for investigation.Investigation of the device was unable to replicate the alleged issue.After fully charging the battery, the unit operated for 11 hours and 0 minutes on the active setting at maximum power index.However, the investigation found a damaged component as l12 was broken.A potential cause could be dropping the device onto hard surface.The stimulator is used to treat pain.The cause of the breakthrough paresthesia sensations is unknown and the investigation findings do not lead to a clear conclusion about the cause of the reported issue.Although the investigation found a damaged component (failure), this did not contribute to the report of breakthrough paresthesia sensations.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.

• 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: 22556261
• Report Number: 3010676138-2025-00150
• Device Sequence Number: 9894552
• Product Code: GZF
• UDI-Device Identifier: 00850051034550
• UDI-Public: (01)00850051034550
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 07/18/2025

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: 01328-DT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NEUROSTIMULATOR, SN: (B)(6), LN: SWO250228.
• Patient Age: 58 YR
• Patient Sex: Female