MAUDE Adverse Event Report: CURONIX LLC FREEDOM PERIPHERAL NERVE STIMULATOR

Model Number STQ4-RCV-A0

Device Problem Off-Label Use (1494)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 11/16/2023

Event Type  Injury  

Manufacturer Narrative

The surgical issue questionnaire was reviewed for potential causes of the reported issue.Based on this review, implanting the stimulator after the expiration date, not prepping the skin with an antiseptic solution, and the patient not attending the post-op visit have been ruled out as potential causes.However, the device was implanted at an off-label location (occipital).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." a curonix representative conducted a review of sterilization and packaging records for the respective product lot; curonix has confirmed that the product was delivered sterile, validated sterilization parameters were used, and sterile barriers were verified to be intact following packaging.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).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, capa is not required. surgical issue rates will continue to be tracked and trended.

Event Description

The patient reported discomfort, neck pain and a stinging sensation.The patient is happy with the pain relief for their headaches.However, the patient will follow up with their physician in 2024.An exact date was not provided and no further information is available at this time.

• 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: 18328414
• MDR Text Key: 330511542
• Report Number: 3010676138-2023-00266
• Device Sequence Number: 1
• Product Code: GZF
• UDI-Device Identifier: 00818225020102
• UDI-Public: (01)00818225020102(17)240101
• 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: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/01/2024
• Device Model Number: STQ4-RCV-A0
• Device Lot Number: SWO220118
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2021
• 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