MAUDE Adverse Event Report: CYBERONICS VAGAL NERVE STIMULATION SYSTEM; STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY

Device Problem Insufficient Information (3190)

Patient Problem Convulsion/Seizure (4406)

Event Date 11/14/2013

Event Type  Injury  

Event Description

It was reported that a patient with a cyberonics vagal nerve stimulation system experienced a seizure on (b)(6) 2013.It was stated that the stimulation device is shut off.No additional information was provided regarding the event.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: VAGAL NERVE STIMULATION SYSTEM
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): CYBERONICS
• MDR Report Key: 17524559
• MDR Text Key: 321135246
• Report Number: MW5131505
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1