MAUDE Adverse Event Report: CYBERONICS CYBERONICS VNS GENERATOR

Model Number 103

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Pain (1994); Tachycardia (2095); Burning Sensation (2146); Neck Pain (2433); Electric Shock (2554)

Event Date 04/18/2014

Event Type  Other  

Event Description

I have the vns for seizure.This is made by cyberonics.It was put in me in (b)(6) 2013.The doctor centrals it with his hand held device and i use a magnet at home on myself when i have a seizure.In 2013, i was fine on the lowest setting that there is.Then in 2014, my doctor was ready to raise the setting on the vns.Once he started to raise and lower the setting on the vns, my ears, jaw, and neck would hurt, then my neck started to burn like it was on fire.I have not been able to be around any loud noises of any kind, it hurt the magnet.I feels like electricity is going straight to the magnet when loud noises are near by.Now in 2016, the magnet is shocking me all the time and it hurts non stop causing my heart to race really fast.Everytime i see the doctor, he says he has never heard of this happening, so he won't take the vns out.I have told the doctor several times, cyberonics several times, and the surgeon who put the magnet in about what has happened.They keep saying they have never heard of this, so they won't do anything about it.All they will do is play with the medicines on having it go up and down in its doses.Cyberonics vns therapy patient essentials.

• Brand Name: CYBERONICS VNS GENERATOR
• Type of Device: CYBERONICS VNS GENERATOR
• Manufacturer (Section D): CYBERONICS
• MDR Report Key: 5620358
• MDR Text Key: 44196434
• Report Number: MW5061976
• Device Sequence Number: 1
• Product Code: LYJ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/17/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 103
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 35 YR
• Patient Weight: 77