MAUDE Adverse Event Report: SOMATICS, LLC THYMATRON; ELECTROCONVULSIVE THERAPY INSTRUMENT

Model Number	SYSTEM IV
Health Effect - Clinical Codes	Memory Loss/Impairment (1958); Brain Injury (2219); Cognitive Changes (2551)
Date of Event	08/23/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Somatics became aware of the complainant's alleged injuries upon receipt of a lawsuit filing.Somatics received no specific information from the treating physicians, specific dates or number of treatments, laboratory results or other objective information to corroborate the complainants' allegations.Moreover, the medical literature provides no evidence of the connection drawn by the complainant between ect treatments and the symptoms reported.Somatics maintains that the thymatron device did not cause or contribute to these injuries.In the (b)(6) 2018 ruling, the fda itself declared that there is no documented proof that ect causes any brain damage.These events were reported to the company through legal channels which limits the company's ability to conduct a full investigation, accordingly, out of abundance of caution and to ensure full compliance with 21 cfr part 803, somatics is reporting this event based on the allegations that were made rather than because it reached any conclusion that the device caused or contributed to these injuries.
Event or Problem Description
Complainant described multiple injuries including brain damage, neurocognitive injuries, permanent memory loss and several others.This was written in a lawsuit filed by the complainant.There were no supporting documents, medical records or health professional reports provided.

• Brand Name: THYMATRON
• Common Device Name: ELECTROCONVULSIVE THERAPY INSTRUMENT
• Manufacturer (Section D): SOMATICS, LLC; 720 commerce drive; suite 101; venice, fl
• MDR Report Key: 9752278
• Report Number: 1420295-2020-00003
• Device Sequence Number: 2366387
• Product Code: GXC
• UDI-Device Identifier: 00850298007003
• UDI-Public: 00850298007003
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: 945120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/25/2020

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: No Information
• Device Model Number: SYSTEM IV
• Device Catalogue Number: EDIV
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 02/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Disability