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

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

Patient Problems Bone Fracture(s) (1870); Memory Loss/Impairment (1958); Hernia (2240); Anxiety (2328); Injury (2348); Depression (2361)

Event Date 04/21/2014

Event Type  Injury  

Event Description

I was admitted to the psychiatric unit at (b)(6) house, in (b)(6), in (b)(6) 2014 with severe depression.After less than a month (i.E., before meds would be most efficacious, and while still in severe depression), i was presented with the option of ect or being committed.I chose the ect with no input from anyone.After 34 rounds of unilateral and bilateral stimulation in less than 3 months, i had 2 mos of complete amnesia, severe memory loss that has not resolved, a broken back, inability to read for more than a year, a drop in iq of at least 40 points, problems with my hand function, loss of livelihood, and disability.I have no recollection from my time in the hosp, except having to make that fateful decision, where their lack of explanation left me only thinking i would not see my daughter if i was committed (i was in the middle of a divorce and lost most of that year)).Now i have trouble recalling past and recent memories.I will most likely never return to my work as a medical editor, for which i went to college.I have not been able to learn new things to reshape my life.I underwent surgery for a herniated iliac in my l4-l5 spinal region in (b)(6) 2015, which the neurologist considered a trauma injury.I had no history of back trauma other than the seizures induced by ect.The herniation was pressing on my spinal cord, leaving me mostly paralyzed from the thighs down.I had the iliac removed and now have rods holding up my spine.My hands, which used to type all day and were fast enough to go verbatim with chiefs of radiology, now create typos, are weak, are painful when i use them, and it is progressing.I had a neurocognitive analysis a couple of years into recovery from this, which showed immense deficiencies for my age and education level, with strength still in language and problem solving, but most everything else at average or well below.The professionals estimated my iq had dropped from about 140 to 100.I developed adult onset add.Social and generalized anxiety took over, which also meant not treating the add.My depression lingered as these new issues took my livelihood away and put me into the poor house on disability.We identified executive function loss.I can't keep track of the day, of appts, and get overwhelmed with more than one thing to track in a day.I couldn't cook for 4 years for fear of walking away and burning the house down.I couldn't read anything for a year, and even now only read my first novel this summer in 2019.They went too far, too fast, ect may work for some people, but 34 rounds in a short time period has destroyed my life.They did not explain the risks associated with this treatment.They did not allow me to confer with anyone before making a decision in a deficient mental state.They leveraged being committed against treating me with what happens to be a cash cow at (b)(6) house.Fda safety report id# (b)(4).

• Brand Name: ELECTROCONVULSIVE THERAPY
• Type of Device: DEVICE, ELECTROCONVULSIVE THERAPY
• MDR Report Key: 8961107
• MDR Text Key: 156786873
• Report Number: MW5089544
• Device Sequence Number: 1
• Product Code: GXC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Disability
• Patient Age: 43 YR
• Patient Weight: 84