MAUDE Adverse Event Report: CURONIX LLC FREEDOM NEUROSTIMULATOR

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

Patient Problem Pain (1994)

Event Date 03/28/2022

Event Type  Injury  

Event Description

The patient reported sharp pain for weeks.Additionally, the patient fell.No additional information was provided and product information was not available.

Manufacturer Narrative

The unintended stimulation/new pain questionnaire was completed by quality with limited information. the patient fell, which is a contributing cause of the sharp pain reported.Other potential causes of pain are improper programming parameters, change in posture or proximity of electrode to target nerve resulting in stimulation of nerves outside target nerves, interference from other electro magnetic sources, migration, and interference from a non-curonix device.  the stimulator is used to treat pain. the cause of the reported issue is due to severe force applied to the implant as the patient fell (user error - patient).Capa-2023-0001 was initiated to investigate and remediate the noncompliance to company reporting procedures.

• Brand Name: FREEDOM NEUROSTIMULATOR
• Type of Device: FREEDOM NEUROSTIMULATOR
• 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: 17232305
• MDR Text Key: 318174179
• Report Number: 3010676138-2023-00091
• Device Sequence Number: 1
• Product Code: GZF
• 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: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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