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

Model Number EDIV

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

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Somatics became aware of this event through the anonymously submitted medwatch patient report provided to fda for event date of (b)(6) 2018 and submitted to the fda on (b)(6) 2020.This report does not provide any contact information for the complainant, treating physician or facility, nor any additional information about the patient, 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., because no doctor, hospital or other information was provided.Because of the lack of identifying information and specifics in the report, somatics is unable to follow up with any involved parties to learn more about what may have happened and to confirm whether the complainant was even treated with its thymatron device.Moreover, the medical literature provides no evidence of the connection drawn by the complainant between ect treatment and the symptoms reported.Although the company has determined that the subject event in this mdr is likely not reportable, because somatics is unable follow-up with the complainant or otherwise affirmatively determine whether the device caused or contributed to the event, and/or whether the ect device in question was even the one manufactured by somatics, the company is submitting this report to fda in an abundance of caution and to ensure full compliance with 21 cfr part 803.

Event Description

Several memory, language and other issues alleged.

• Brand Name: THYMATRON
• Type of Device: ECT INSTRUMENT
• 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
• MDR Report Key: 10017455
• MDR Text Key: 194315925
• Report Number: 1420295-2020-00005
• 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: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: EDIV
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2020
• 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
• Removal/Correction Number: MW 5094073
• Patient Sequence Number: 1
• Patient Outcome(s): Other