MAUDE Adverse Event Report: CYBERONICS, INC. VNS THERAPY PATIENT ESSENTIALS; STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY

Lot Number 893990

Patient Problems Radiation Burn (1755); Headache (1880); Failure of Implant (1924); Burning Sensation (2146); Sleep Dysfunction (2517); Hallucination (4428); Suicidal Ideation (4429); Unspecified Gastrointestinal Problem (4491)

Event Date 09/07/2023

Event Type  Injury  

Event Description

Hello, i am (b)(6) i was diagnosed with epilepsy at the age of three.I began to take medication for "my" epilepsy.When i was a on - adult.Epilepsy, it did not get any better.So at the age of middle twenty's or thirty's, my doctor thought i would be a great "candidate".At the (b)(6).For a vns therapy patient essentials by (b)(6).For the partial seizures that i was having 4 to 5 times a day.The vns therapy pt essentials implant was programmed on (b)(6) 2013.I "healed" great but then came along on (b)(6) 2017 i had a doctor's visit."the doctor started to me" so i would need surgery because the cord was tangled.For another vns therapy pt essentials.As years passed in 2017 i began to hear messages telling me to kill myself.Then my gi tract would have a very bloating feeling.So i thought i was pregnant.So i started beating my gi tract.So after i was working at (b)(6) located in (b)(6), i could hear voices coming from my remote the honda accord.Two black females.Saying she is hired, she will be awake soon.Then after i had a bad day at work smashing the remote hearing the voices at work then two black females also watching, i work til my shift was over.I began to hear voices from my ear canal the left, right, then they had access to control my system some how.Making i take many restroom breaks doing bed time.Having headaches.Very upset stomach, when my cycle would be on for 4 days or more.Burning my nail beds, skin very dry, damaging my hair, using conditioner lots, lots to form shape of the brain or head.So as of today i cannot sleep at night burning, "i very bad threats," i will kill you.We should have never cybercrime her.She is not a mad person.On (b)(6) 2023.Vns therapy patient essential (cyberonics) zonisamide, levetiracetam, caplyta, carbamazepine, i purchased a "lively" mobile device from the walgreens located on (b)(6).After a year pasting i was burned very badly on the back of my neck.So i did make an appointment with my family doctor.It was due to the rope unclean around my neck.I did report the problem to lively, lively sent "i" a hip wear to wear on my hip, i have radiation burns on the face, whole organ.

• Brand Name: VNS THERAPY PATIENT ESSENTIALS
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): CYBERONICS, INC.; 100 cyberonic blvd; houston TX 77058
• MDR Report Key: 18072807
• MDR Text Key: 327394387
• Report Number: MW5147761
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• 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: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 893990
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: "CAPLYTA" 42 MG LUMATEPERAX CAPSULES TAKE AT BED TIME; "LEVETIRACETOM"; CARBAMAZEPINE 200MG; GNE SELECT CALCIUM GUMMY 500MG; LOVETIRACETAM 1000MG TABLET; ZONISAMIDE 100MG 3 CAPSULES BY MOUTH NIGHTLY
• Patient Outcome(s): Disability; Hospitalization
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Race: Black Or African American