MAUDE Adverse Event Report: CYBERONICS / LIVANOVA USA, INC. VNS THERAPY; STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY

Lot Number 893990

Patient Problems Headache (1880); Pyrosis/Heartburn (1883); Itching Sensation (1943); Memory Loss/Impairment (1958); Undesired Nerve Stimulation (1980); Blurred Vision (2137); Burning Sensation (2146); Obstruction/Occlusion (2422); Sleep Dysfunction (2517); Constipation (3274)

Event Type  Injury  

Event Description

Greetings all staff i am (b)(6).I have a vns.I have had the vns for 10 years now but there seems to be a problem with the foods that i eat and drink.I also take caplyta for hearing voices, hallucinations before bed but after the caplyta peaks in during bedtime my feet begin to burn and have this tingling feeling, this morning (b)(6) 2023 i was very hot on the chest around 8:00am.I had alfredo chicken helper with cheese around 7:00 pm.(b)(6) 2023 during bedtime i feet beginning to burn very bad.I have air in my gi tract while i¿m eating example: a salad, peanut butter, while eating it makes my gi tract very tight.I cannot eat any sugar or salt not much because it makes i very sleepy.Or sometimes i will take a nap.I do a lot of restroom breaks after drinking water.I used to have alto of zips in my face but not as much as i use to have.But the vns that i have the unknown suspects have programmed my systems to make them do things.Making my stomach very upset feeling as if i¿m about to have a seizure.Headaches, blurry visions, itchy skin, the hunger cure even when i have eaten an hour ago the next hour will come and i¿m hungry again.I cannot put any lotions on my skin it, makes my skin very dry break outs and itchy.I cannot let my waste out when need sometimes i have bowel obstruction.Sometime when i¿m letting the waste out i can smell what i have eating breathing out.I cannot sleep good at night i hear unknown suspects i do not know so this morning i was keep awake and had a home visit for the doctor i was very sleepy (b)(6) 2023.I dream alto but its humans that i know shooting firearms dying humans, it feels as if someone is on my shoulder when im asleep but it¿s not.I cannot remember some things but if so it¿s like a flash comes then i can remember.When i first started the caplyta during bedtime i could feel i brain washing away memory¿s from my brain and the unknown suspects saying they were by a railroad track running and what do we do.Threats i will kill you, i will kill your whole family, i hope you die, i hate light skins why are light skins so smart.They will send message to my brain to get i to think about things or they will say what she¿s thinking.Is she asleep or she about to shower her skin is to clean to be on drugs.She is not a bad person.They can see i sleeping everywhere i go what i buy or eat or drink or if i¿m happy or sad or who i¿m chatting with on my devices or company they can hear everything they will sting my vns implant or my cord scan my body after showering scan my lips while sleeping.Make i sneeze or have burning eyes making i butt ox hurts or scanning i urine to measure the amount to restroom.Saying i see her hands its not on the criminal justice list her feet or to white all she does is do education and business.Harassing i everyday bullying i everyday threats spying on i everyday yelling saying bad words.But i do have names for you guys this have been going on since 2017 since i knew that the unknown suspects program i with the vns trying to make i run over humans and hit humans, making my system do things with information technology.(b)(6) thanks!! (b)(6) 2023.

• Brand Name: VNS THERAPY
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): CYBERONICS / LIVANOVA USA, INC.
• MDR Report Key: 17923773
• MDR Text Key: 325717308
• Report Number: MW5146854
• 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: 10/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2023
• Device Lot Number: 893990
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/11/2023
• Patient Sequence Number: 1
• Treatment: CAPLYTA 42 MG.; CARBAMAZEPINE 200 MG TABLET.; GNC SELECT CALCIUM GUMMY 500 MG.; LEVETIRACETAM 1000.; ZONISAMIDE 100 MG CAPSULE.
• Patient Outcome(s): Disability
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American