MAUDE Adverse Event Report: SOMATICS, LLC THYMATRON BY SOMATICS; ECT DEVICE

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

Patient Problems Unspecified Infection (1930); Memory Loss/Impairment (1958); Pain (1994); Paralysis (1997); Cognitive Changes (2551)

Event Date 11/17/2018

Event Type  Injury  

Manufacturer Narrative

Patient identified the hospital where ect treatments were received.A review of our files showed that the hospital purchased a mecta model d prior to 1988 which they stopped using prior to 4/18/1990.The hospital switched to a somatics thymatron device at that time, which we verified they have continued to use through 2014 and likely to the present day.The patient's last ect treatment was in 2009.Thus, at least the last 19 years of the patient's treatments were not done with a mecta device.

Event Description

Various medical problems claimed to be consequence of more than 80 maintenance bilateral ect treatments, including: memory loss, cognitive impairments, neurological problems following infections.Patient says "i now have a new development.Any time i get my bacterial, viral or fungal infection, it goes directly to my brain triggering painful dystonia.Airborne pathogens go directly to my brain at times triggering painful dystonia, dyskinesia-type erratic movements, parkinsonism-type gait and most recently diaphragmatic paralysis.I believe this is a direct result of ect's hypertensive surge bursting lesions causing blood-brain-barrier hyperpermeability." "the data listed is merely the most recent incident." summarizing: the patient completed ect in 2009.She is now experiencing neurological problems following infections.She believes this to be a result of her ect therapy.See medwatch report mw5081540 for full details.

• Brand Name: THYMATRON BY SOMATICS
• Type of Device: ECT DEVICE
• Manufacturer (Section D): SOMATICS, LLC; 720 commerce drive, unit 101; vencie FL 34292
• Manufacturer (Section G): MECTA CORPORATION; 19799 sw 95th avenue suite b; tualatin OR 97062
• Manufacturer Contact: robin nicol ; 19799 sw 95th avenue suite b; tualatin, OR 97062 ; 5036126780
• MDR Report Key: 8437679
• MDR Text Key: 139413959
• Report Number: 3020533-2019-00001
• Device Sequence Number: 0
• Product Code: GXC
• Reporter Country Code: US
• PMA/PMN Number: K965070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 03/20/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other