MAUDE Adverse Event Report: SOMATICS, LLC SOMATICS, LLC; THYMATRON SYSTEM IV

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

Patient Problems Memory Loss/Impairment (1958); Brain Injury (2219); Cognitive Changes (2551)

Event Type  Injury  

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 caused 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 this injury.Somatics will supplement this report accordingly.

Event Description

Ms.(b)(6) filed a lawsuit claiming multiple "serious" injuries.Some of these alleged injuries are: brain damage; neurocognitive injuries; permanent memory loss; and several other alleged injuries since this is just the beginning of the lawsuit somatics will not be able to confirm any of these allegations.

• Brand Name: SOMATICS, LLC
• Type of Device: THYMATRON SYSTEM IV
• Manufacturer (Section D): SOMATICS, LLC; suite 101; 720 commerce drive; venice FL 34292
• Manufacturer (Section G): SOMATICS, LLC; suite 101; 720 commerce drive; venice FL 34292
• Manufacturer Contact: david mirkovich ; suite 101; 720 commerce drive; venice, FL 34292 ; 8006426761
• MDR Report Key: 8545182
• MDR Text Key: 142931785
• Report Number: 1420295-2019-00005
• Device Sequence Number: 1
• Product Code: GXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 945120
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other