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

Model Number	PDBT-915-2K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient reported burn marks on their skin as they placed the antenna directly on their skin.The patient reported the waa did not overheat and they were receiving pain relief.The wounds have healed, the patient will wear the device again, and place something between the antenna and the skin.
Additional Manufacturer Narrative
The waa heat related issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, the device overheating and the device causing a burning sensation to the skin have been ruled out as potential causes.However, the patient was wearing the antenna directly on the skin causing the marks.The physician believes the wounds were pressure wounds.Rma 2023-08533 was not returned to curonix headquarters for engineering investigation as the reported issue was attributed to user error.The stimulator is used to teat pain. the cause of the reported issue is due to non-compliance to the ifu as the patient wore the antenna directly on their skin (user error - patient).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in waa heat related failure.Waa heat related failure rates remain acceptably low; thus, capa is not required.Waa heat related failure rates will continue to be tracked and trended.

• Brand Name: FREEDOM PERIPHERAL NERVE STIMULATOR
• Common Device Name: WEARABLE ANTENNA 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: 16979884
• Report Number: 3010676138-2023-00066
• Device Sequence Number: 6480564
• 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): 05/22/2023

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: 00596-DT
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2023
• Initial Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2022
• 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
• Patient Age: 51 YR
• Patient Sex: Female