MAUDE Adverse Event Report: ELECTROCONVULSIVE TREATMENT MACHINE; DEVICE, ELECTROCONVULSIVE THERAPY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Emotional Changes (1831); Memory Loss/Impairment (1958); Cognitive Changes (2551); Confusion/ Disorientation (2553)

Event Date 04/04/2011

Event Type  Injury  

Event Description

Received 16 ect treatments.First of 6 at one facility.They did a ct scan prior to ect and determined possible brain atrophy.Treatments were discontinued with no explanation.Facility that first recommended ect then did iq and psychological testing then did 10 more treatments.I scored average high to superior on test and was to be given another test after ect treatments.After 10th treatment at second facility (16 total), they stopped with no explanation.Would not return calls, i was never given f/u testing.Prior to ect i had been an executive assistant for more than 30 years and helped my husband start up and run two businesses.Since ect i have not been able to work and had to go on ssi disability.My husband of 23 years divorce me in 2014 when i could no longer be the person i had been prior to ect and could not do the book-work for the businesses.I am a shell of who i was before.All of my cognitive / executive functioning has been negatively effected.I cannot control my emotion.I get flustered easily and it is humiliating.My memory is all messed up.Events as much as 2 to 3 years before are gone.I can still remember minute details of insignificant things but may forget a conversation i just had recently with someone.I get confused, always forget where i put things, cannot get things organized and live with piles of "stuff" all over my house.I try to organize but get overwhelmed.Prior to ect had gone through emdr for ptsd and was doing better.Since ect nightmares every single night and am up and down all night.I have an intense startle reflex which is extremely embarrassing.I cannot be in groups.I used to enjoy "cranking up the oldies and bonding with my house" (intense cleaning).Now music gets on my nerves and i can rarely stand listening to something i used to enjoy.Cannot go to a restaurant because i cannot tune out noises and that drive me crazy (i.E., forks clanking on plates, cell phones ringing, cash register sound, conversation around me, waitresses taking orders etc).I just cannot tolerate chaos and drama of any kind.I used to sit in weekly meetings with 10 or more executives, some present, some on teleconference and / or video conference from other countries and take minutes for 2 to 4 hours weekly), then type and distribute them.Sometimes there were 3 or more conversations going on at the same time and i had no problem distinguishing what the important details were that needed to be documented.There is more but my brain is getting tired from thinking and typing all these details.I do not know about testing section other than what i said in previous answer.No drs believe me that ect caused this, so none have done any tests.I am scheduled to see a neurologist this month and hope that they will believe me and try to help figure it out.Fda safety report id# (b)(4).

• Brand Name: ELECTROCONVULSIVE TREATMENT MACHINE
• Type of Device: DEVICE, ELECTROCONVULSIVE THERAPY
• MDR Report Key: 8600540
• MDR Text Key: 144963901
• Report Number: MW5086547
• Device Sequence Number: 1
• Product Code: GXC
• 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: 05/07/2019
• 2 Devices were Involved in the Event: 1 2

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/09/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability