MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number	FR8A-TRL-A0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	03/22/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The unintended stimulation/new pain questionnaire was completed by quality with limited information. potential causes of an achy burning feeling are unintended stimulation, improper programming parameters, change in posture or proximity of electrode to target nerve resulting in stimulation of nerves outside the target nerves, interference from other electromagnetic sources, interference from a non-curonix device, and patient contraindicating conditions.However, the patient's issue was resolved after the device was reprogrammed.The stimulator is used to treat pain. the cause of the reported issue is due to incorrect programming parameters as the patient's issue was resolved after the device was reprogrammed (user error - clinical representative).Capa: 2023-0001 was initiated to investigate and remediate the noncompliance to company reporting procedures.
Event or Problem Description
The patient reported an achy burning feeling in their buttock which started during the procedure.The device was reprogrammed and the patient was no longer getting a burning pain in their buttock.

• Brand Name: FREEDOM PERIPHERAL NERVE STIMULATOR
• Common Device Name: PERIPHERAL NERVE STIMULATOR
• 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: 17301370
• Report Number: 3010676138-2023-00100
• Device Sequence Number: 12514791
• Product Code: GZF
• UDI-Device Identifier: 00818225020792
• UDI-Public: (01)00818225020792(17)230901
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K171366
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 07/11/2023

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 Expiration Date: 09/01/2023
• Device Model Number: FR8A-TRL-A0
• Device Lot Number: SWO210905A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2021
• 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: 48 YR
• Patient Sex: Unknown