MAUDE Adverse Event Report: MECTA CORP. MECTA SPECTRUM; DEVICE, ELECTROCONVULSIVE THERAPY

Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Emotional Changes (1831); Headache (1880); Memory Loss/Impairment (1958); Nausea (1970); Pain (1994); Loss of Vision (2139); Vomiting (2144); Dizziness (2194); Arthralgia (2355); Reaction (2414); Confusion/ Disorientation (2553)
Date of Event	04/06/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
I had numerous adverse reactions to over 30 antidepressants and antipsychotic medications and the doctor recommended electroshock therapy, which i had 9 treatments done after being evaluated and educated about the process and was told that i would only have mild temporary memory loss.Which couldn't be further from the truth, in (b)(6) 2016 immediately after my last treatment i started telling my provider about the severe headaches and vision loss but he ignored my issue.The issues continued to come and get worse and worse.I have a headache 24/7, vision issues, nausea/vomiting, severely painful muscles and joints, lost my memory that still has not return, completely forgot how to do my job, anger, agitation, increased suicidal thoughts, my depression has never improved whatsoever, dizziness, confusion, not able to focus or remember what i'm supposed to do day to day.I could go on but my other concern is the fact that i asked my psychiatrist at every visit for a referral to a neurologist but after a year of asking i was forced to go to another doctor to get a simple referral.My psychiatrist continues to deny that my treatments had anything to do with any of these other issues.I've also found out information about ect's that was never told to me.These treatments have ruined my life and had to go onto disability in (b)(6) 2017.Isn't there a law about full disclosure?.

• Brand Name: MECTA SPECTRUM
• Common Device Name: DEVICE, ELECTROCONVULSIVE THERAPY
• Manufacturer (Section D): MECTA CORP.
• MDR Report Key: 6756529
• Report Number: MW5071311
• Device Sequence Number: 1223768
• Product Code: GXC
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Type of Report: Initial
• Report Date (Section B): 07/28/2017

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?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention; Disability
• Patient Age: 47 YR
• Patient Weight: 45