MAUDE Adverse Event Report: ECT; ELECTROCONVULSIVE THERAPY

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Memory Loss/Impairment (1958); Cognitive Changes (2551)

Event Type  Injury  

Event Description

This is now my third attempt to write this because i keep deleting the form.I suffer from bipolar depression and was desperate to find something that would work so i could go back to work.None of the medication worked so i did 12 bilateral ect treatments back in 2008 or 2009.They were not successful.I was told that i would have memory problems for up to six months and then things would go back to normal.It's now 6 or 7 years and i have some long term memory problems but i mainly suffer from short term memory problems.I can't tell you how frustrating this is for me.I can't find simple words and try to describe it so someone can tell me what i'm looking for.I can watch a tv show or movie and not remember it.I watch it again like it's the first time.Sometimes i notice the tv show when i'm watching the following week and i don't remember how something happens or when.I've watched but forgotten the previous weeks show so i have to go back and watch the previous weeks show to catch up.Thank goodness for my (b)(6).I am very lucky to have such a patient husband because i am always asking things more than once or twice, searching for words and watching things over again.I used to be able to do complex math problems in my head and now i struggle to enter then into a calculator.My husband said i could do them in my head faster than he could input them into a calculator.That ability is gone.I have difficulty writing things that make sense and find spelling errors.I read it several times and still miss things.I tried to use the dictation feature on my phone but it still didn't all make sense.The most disturbing thing that happened the other day was i looked at my shoe and couldn't think how to tie it.It didn't take long to remember and do it but it has really bothered me.I sometimes joke that my phone is my brain but it really is.I have everything on a calendar with at least 2 reminders.I have alarms and alerts for everything so i don't forget something.I have all contacts listed, including home.I also input address into my map in case i do not know or forget how to get somewhere.I have an app on my phone for my grocery list.I input items on the list and my husband can add or delete items from his phone or computer.It has a box to check it off as you get it and when i think i'm finished, i click the trash can.If everything is gone then i got everything otherwise it shows me what i missed.I still suffer from severe depression with the occasional mania so nothing has worked.I know ect is a very effective treatment for many but it has been a nightmare for me.I ask that you continue to keep this high risk and do further investigations into the possible side effects.I wish i had known this was a possibility because i wouldn't have done it.I have also been checked for a stroke and my husband said he would have considered alzheimer's if it didn't begin with the treatments.

• Brand Name: ECT
• Type of Device: ELECTROCONVULSIVE THERAPY
• MDR Report Key: 4652099
• MDR Text Key: 5680827
• Report Number: MW5041771
• Device Sequence Number: 1
• Product Code: GXC
• 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: 03/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Patient Sequence Number: 1
• Treatment: OMEPRAZOLE; CLONAZEPAM AS NEEDED UP TO 2 MG; METOPROL TAR; RX MEDS: LEVOTHYROXIN; BUPROPION; LIOTHYRONINE; OTC MEDS: 81 MG ASPIRIN PER DAY FOR HEART; LAMOTRIGINE; SIMVASTAIN
• Patient Outcome(s): Disability
• Patient Age: 45 YR