MAUDE Adverse Event Report: SOMATICS, LLC SOMATICS; THYMATRON

Model Number N / A

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

Patient Problem Injury (2348)

Event Date 09/01/2016

Event Type  Injury  

Manufacturer Narrative

Xsomatics became aware of this event through the maude website in early (b)(6).The patient submitted medwatch report provided by the fda was received april 20, 2020.The patient alleged the event occurred (b)(6) 2016.This report does not provide any contact information for the treating physician or facility, nor any additional information about the treatment or circumstances surrounding the reported event.The report also does not provide any laboratory results or other objective information to corroborate the complainant's description of the adverse effects suffered in relation to electroconvulsive therapy.In addition, the report indicates a lack of knowledge as to which device model the patient was treated with.Somatics sent a return receipt letter requesting documentation of the missing information above.When received back, somatics will update this report if it is deemed warranted.

Event Description

Multiple injuries alleged.

• Brand Name: SOMATICS
• Type of Device: THYMATRON
• Manufacturer (Section D): SOMATICS, LLC; 720 commerce drive; suite 101; venice, fl
• Manufacturer (Section G): SOMATICS, LLC; 720 commerce drive; suite 101; venice, fl
• Manufacturer Contact: david mirkovich ; 720 commerce drive; suite 101; venice, fl ; 2346761
• MDR Report Key: 10032212
• MDR Text Key: 190348703
• Report Number: 1420295-2020-00008
• 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: 03/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: N / A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/20/2020
• Was Device Evaluated by Manufacturer?: No
• 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