MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number STQ4-RCV-A0

Device Problem Off-Label Use (1494)

Patient Problem Pain (1994)

Event Date 01/11/2024

Event Type  Injury  

Event Description

The patient reported migration and pain when they try to say some words.Although x-rays were not taken to confirm migration, the migration is visible when looking at the patient's face.The physician decided not to revise or explant the device as the patient is receiving some relief.Curonix became aware of the report of pain on (b)(6) 2024.

Manufacturer Narrative

The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting a damaged neurostimulator, inadequate fixation, severe force applied to the implant, and excessive twisting, bending, or stretching have been ruled out as potential causes.However, the device was implanted off-label as it was implanted at the infraorbital nerve (cheek).Per freedom peripheral nerve stimulator system implantation of neurostimulator instructions for use, 05-30200, "the freedom pns system is not intended to treat pain in the craniofacial region." the stimulator is used to treat pain.The cause of pain is migration and the cause of migration is unknown.However, the device was implanted off- label as it was implanted at the infraorbital nerve (user error-clinician).Rates reviewed at the most recent complaint trending meeting do not indicate a significant increase in surgical issues.Surgical issue rates remain acceptably low; thus, a capa is not required at this time.Surgical issue rates will continue to be tracked and trended.

• Brand Name: FREEDOM PERIPHERAL NERVE STIMULATOR
• Type of Device: PERIPHERAL NERVE STIMULATOR
• 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: 18859627
• MDR Text Key: 337146577
• Report Number: 3010676138-2024-00034
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00818225020402
• UDI-Public: (01)00818225020402(17)230401
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2023
• Device Model Number: STQ4-RCV-A0
• Device Lot Number: SWO210408
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/18/2021
• 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