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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Memory Loss/Impairment (1958); Therapeutic Effects, Unexpected (2099); Cognitive Changes (2551)

Event Date 02/08/2019

Event Type  Injury  

Event Description

I received electroconvulsive therapy from (b)(6) 2018 to (b)(6) 2019.I had 20 treatments total.I received treatments at (b)(6) health center in (b)(6).The ect doctor's name was dr.(b)(6).After the first treatment i noticed i could not remember a vacation i had went on that past summer.After a few more treatments i noticed i could not remember anything at all prior to the treatments.According to my mom and sister who took me to my treatments, the treatments were unilateral, first on the left side and then switched to the right side for reasons i do not know.I am still suffering cognitive impairment as a result of the treatments.I have not been able to work since (b)(6) 2019.I returned to work shortly after i stopped treatments (i stopped treatments because my memory, focus and concentration was so poor although i was encouraged to continue treatments) because i could no longer perform my job.I met with dr.(b)(6) shortly after i stopped treatments to discuss my memory problems.She told me i would return to baseline functioning within a few weeks and my memories would return, neither have happened.I have seen two neurologists regarding my memory issues.They both said it is likely lingering side effects from the ect.I got an mri and eeg both of which were normal.I cannot become licensed as a mental health counselor because i cannot take the test.I have a masters in school counseling and a post masters certificate in mental health counseling.Although my memory has improved since i stopped treatment i am still not nearly close to baseline functioning.I experience brain fog and confusion all the time.I received my medical record from (b)(6) health center, it did not include my consents, conversations with the doctor or nurses nor the type of machine that was used.I called the medical records department and they said my records have since been moved to an off-site location and they were going to retrieve them and look for that information.As for the type of machine, i was informed that would not be in my records.I left multiple messages over the last few months to speak with dr.(b)(6) or any nurse to find out what machine was used and address my lingering side effects.Nobody will return my call.The machine that was used left me with cognitive side effects and affect my everyday ability to function.Fda safety report id#: (b)(4).

• Brand Name: ELECTROCONVULSIVE THERAPY
• Type of Device: DEVICE, ELECTROCONVULSIVE THERAPY
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 9987561
• MDR Text Key: 188973698
• Report Number: MW5094232
• 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: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2020
• 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): Disability
• Patient Age: 32 YR
• Patient Weight: 51