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 02/22/2022

Event Type  Injury  

Event Description

The patient reported no pain reduction and severe pain.The clinical representative explained the severe pain was the original pain being treated.The patient's device was reprogrammed and the patient is satisfied with therapy.

Manufacturer Narrative

The unintended stimulation/new pain questionnaire was completed by quality with limited information. potential causes of unintended stimulation/overstimulation 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-curonix device and migration.The clinical representative reprogrammed the device and the issue was resolved.The stimulator is used to treat pain. the cause of the reported issue is due to incorrect programming parameters (user error - clinical representative).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: 17374376
• MDR Text Key: 319558406
• Report Number: 3010676138-2023-00133
• 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: 02/22/2022
• 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