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

Model Number	PDBT-915-2K
Medical Device Problem Codes	Use of Device Problem (1670); Detachment of Device or Device Component (2907); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	05/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported their transmitter assembly was getting hot and caused a burning sensation to the skin.The overheating did not cause tissue damage or require medical intervention.The patient was provided a replacement transmitter assembly.
Additional Manufacturer Narrative
The investigation found the rf connector was damaged caused by mishandling.The investigation found the rf connector was damaged caused by mishandling.The sma rf connector solder joints to 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.Additionally, visual inspection revealed one of the housing screws was very rusty and could not be unscrewed.The investigation also found the pcb screws were loose as the torque driver used during manufacturing was out of tolerance.Due to the damaged rf connector, the device does not operate and thermal imaging of the device while operating could not be obtained.For the report of overheating: thermal imaging was used to verify the outside and internal temperature of the device while charging.Results are as follows: outside thermal temperature while charging: 31.2°c internal thermal temperature while charging: 31.9°c the outside thermal temperature while charging was 31.2°c, which is below the product requirements specification of 41°c (106°f).Based on the thermal imaging, there is no evidence of thermal damage and the product met temperature specifications.Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in broken connector or out of tolerance.Broken connector and out of tolerance rates remain acceptably low; thus, capa is not required.Broken connector and out of tolerance rates will continue to be tracked and trended.Refer to issue (b)(4) for additional investigation details for the loose pcb screws.

• 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: 19390351
• Report Number: 3010676138-2024-00091
• Device Sequence Number: 18092572
• 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): 05/24/2024

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: 00829-DT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2023
• 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 Sex: Female