MAUDE Adverse Event Report: CURONIX LLC FREEDOM NEUROSTIMULATOR

Device Problem Off-Label Use (1494)

Patient Problems Pain (1994); Electric Shock (2554)

Event Date 04/06/2022

Event Type  Injury  

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, off label-use, change in posture or proximity of electrode to target nerve resulting in stimulation of nerve outside the target nerve, interference from a non-stimwave, and migration.However, the device was implanted in an off-label location as it was implanted to target the occipital nerve.The stimulator is used to treat pain. the cause of the reported issue is due to off-label use as the device was implanted at the occipital nerve (user error - clinician).Capa-2023-0001 was initiated to investigate and remediate the noncompliance to company reporting procedures.

Event Description

The patient reported overstimulation and their ears hurt when the device is in use.Reprogramming attempts were made.No additional information provided.

• 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: 17352889
• MDR Text Key: 319389175
• Report Number: 3010676138-2023-00117
• 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

• 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: 04/06/2022
• Initial Date FDA Received: 07/19/2023
• 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