MAUDE Adverse Event Report: SOMATICS, LLC SOMATICS; THYMATRON SYSTEM ECT INSTRUMENT

Model Number	System IV
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The company has received a legal complaint and is unable to investigate due to legal constraints within the allotted reporting period.As a result, the company is reporting out of abundance of caution based solely on the allegations contained in the lawsuit.If and when the company is permitted to conduct a proper investigation, it will be able to determine if its device was used in the alleged injuries.The information currently available suggests that it is unlikely.The december 2018 fda publication stated there is no proof that ect causes these types of injury.Somatics will supplement this report accordingly.
Event or Problem Description
Lawsuit was filed in california claiming many serious injuries including brain damage, memory loss and other problems.Dates of treatments were over four years ago.

• Brand Name: SOMATICS
• Common Device Name: THYMATRON SYSTEM ECT INSTRUMENT
• Manufacturer (Section D): SOMATICS, LLC; 720 commerce drive; suite 101; venice FL 34292
• Manufacturer (Section G): SOMATICS, LLC; 720 commerce drive; suite 101; venice FL 34292
• Manufacturer Contact: david mirkovich ; 720 commerce drive; suite 101; venice, FL 34292
• MDR Report Key: 15745876
• Report Number: 1420295-2022-00008
• Device Sequence Number: 17605060
• Product Code: GXC
• UDI-Device Identifier: 00850298007003
• UDI-Public: 00850298007003
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: 945120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/07/2022

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
• Device Model Number: System IV
• Device Catalogue Number: EDIV
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Disability
• Patient Sex: Female