MAUDE Adverse Event Report: CURONIX LLC FREEDOM NEUROSTIMULATOR

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

Patient Problems Pain (1994); Impaired Healing (2378)

Event Date 04/07/2022

Event Type  Injury  

Event Description

The patient reported severe back pain and scars not healing properly.No additional information available.

Manufacturer Narrative

The surgical issue questionnaire was completed by quality with limited information. potential causes of pain are incorrect programming parameters, change in posture or proximity of electrode to target nerve resulting in stimulation of nerves outside the target nerve, stimulator electrical failure, interference from another electro magnetic sources, and migration.Potential causes of wound not healing are patient non-compliance (touching or picking at the wound), implanting non-sterile device, surgical (not irrigating the site with antibiotics solution before closure, not using antibiotics pre-operatively, not implanting in sterile field, not prepping skin with antiseptic solution, using inappropriate tools, multiple tunneling attempts), and patient contraindicating conditions.The stimulator is used to treat pain. the cause of the reported issue is unknown. therefore, conclusion has been selected as no problem/fault found.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: 17371846
• MDR Text Key: 319505240
• Report Number: 3010676138-2023-00124
• Device Sequence Number: 1
• Product Code: GZF
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 07/21/2023

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/07/2022
• Initial Date FDA Received: 07/21/2023
• 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