MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number FR8A-TRL-A0

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 05/12/2022

Event Type  Injury  

Manufacturer Narrative

The unintended stimulation/new pain questionnaire was completed by quality with limited information. potential causes of pain are migration, interference from a non-curonix device, excessive twisting or stretching, severe force applied to the implant, improper programming parameters, implanting the device in an off-label location, and patient contraindicating conditions.The stimulator is used to treat pain. the cause of the reported issue is due to excessive twisting or stretching as the patient bent over, not following post-op instructions (user error - patient).Capa-2023-0001 was initiated to investigate and remediate the noncompliance to company reporting procedures.

Event Description

The patient reported pain after bending over.No additional information was provided.

• Brand Name: FREEDOM PERIPHERAL NERVE STIMULATOR
• Type of Device: 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: 17302152
• MDR Text Key: 319040272
• Report Number: 3010676138-2023-00102
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00818225020792
• UDI-Public: (01)00818225020792(17)230901
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171366
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/12/2022
• Initial Date FDA Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Female