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

Model Number	PDBT-915-2K
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	05/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As a result of the loose battery, the battery was punctured and leaked, and cannot delivery therapy.For the report of overheating: thermal imaging was used to verify the outside temperature of the device while charging, the internal temperature of the device while charging, the outside temperature of the device while operating, and the internal temperature of the device while operating.Results are as follows: outside thermal temperature while charging: 30.5°c.Outside thermal temperature while operating: 29.4°c.Internal thermal temperature while operating: 31.0°c.The outside thermal temperature while charging was 30.5°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.Reference capa-0042 for additional investigation details for the loose battery.
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.

• 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: 19354974
• Report Number: 3010676138-2024-00090
• Device Sequence Number: 7678051
• 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): 05/20/2024

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: 00372-S
• 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: 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2020
• 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