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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Seizures (2063)

Event Date 07/26/2010

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 patients'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.This is the second medwatch report filed by this patient years after the ect course of treatment.This report describes a new set of adverse events not reported previously.

Event Description

After dental procedure requiring local anesthetic patient experienced what dentist believed was a seizure.No cause found after evaluation at two hospitals.In 2017 and again in 2018 patient received lidocaine for a medical procedure and experienced what medical staff thought was a seizure.Patient had no prior history of such sensitivities.Patient finished ect in 2009 and believe ect to be the cause of the sensitivity to anesthesia.

• Brand Name: THYMATRON BY SOMATICS
• Type of Device: ECT DEVICE
• Manufacturer (Section D): SOMATICS, LLC; 720 commerce drive, unit 101; vencie, fl
• Manufacturer (Section G): MECTA CORPORATION; 19799 sw 95th avenue suite b; tualatin, or
• Manufacturer Contact: robin nicol ; 19799 sw 95th avenue suite b; tualatin, or ; 6126780
• MDR Report Key: 10053471
• MDR Text Key: 190893196
• Report Number: 3020533-2020-00001
• Device Sequence Number: 1
• Product Code: GXC
• Combination Product (y/n): N
• 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: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/17/2020
• 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