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 05/13/2022

Event Type  Injury  

Event Description

The patient reported pain and migration was confirmed.An explant procedure was performed.However, the date is unknown.Reimplantation is not being considered for psychological reasons.No additional information provided.

Manufacturer Narrative

The unintended stimulation / new pain 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 nerve outside the target nerve, interference from a non-stimwave device, off-label use, patient contraindicating conditions, and migration.Potential causes of migration are inadequate fixation, severe force applied to implant (patient fall, accident), excessive twisting or stretching, posture, off-label use, and patient contraindicating conditions.The stimulator is used to treat pain. the cause of the pain is migration.However, the cause of migration 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: 17356608
• MDR Text Key: 319376340
• Report Number: 3010676138-2023-00121
• Device Sequence Number: 1
• Product Code: GZF
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 07/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2023
• 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: 05/13/2022
• 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
• Patient Outcome(s): Required Intervention