MAUDE Adverse Event Report: MECTA CORPORATION MECTA SPECTRUM ; DEVICE, ELECTROCONSULSIVE THERAPY

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

Patient Problems Headache (1880); Memory Loss/Impairment (1958)

Event Date 06/24/2015

Event Type  Injury  

Event Description

I have amnesic disorder and following the ect my memory was severely affected.I already had severe memory loss and after ect i couldn't remember names of distant family, friends.My memory was i feel like almost erased.I could not remember hardly anything.I had extreme problems trying to concentrate.I also started suffering with severe migraine headaches.Fda safety report id# (b)(4).

• Brand Name: MECTA SPECTRUM
• Type of Device: DEVICE, ELECTROCONSULSIVE THERAPY
• Manufacturer (Section D): MECTA CORPORATION
• MDR Report Key: 9883050
• MDR Text Key: 185222057
• Report Number: MW5093931
• 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: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Weight: 61