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

Model Number N/A

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

Patient Problem Injury (2348)

Event Date 07/26/2010

Event Type  Injury  

Manufacturer Narrative

Somatics became aware of this event on the maude website in early april.The patient submitted medwatch report provided by fda was received on april 20, 2020.It referenced the event date of (b)(6) 2010.It does not provide any contact information for the treating physician or facility, nor any additional information about the 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.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.Because of the lack of identifying information and specifics in the report, somatics is unable to determine if 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 to determine 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

Many serious injuries were claimed.

• Brand Name: SOMATICS ECT INSTRUMENT
• 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: 10032208
• MDR Text Key: 195949492
• Report Number: 1420295-2020-00006
• Device Sequence Number: 1
• Product Code: GXC
• UDI-Device Identifier: 00850298007003
• UDI-Public: 00850298007003
• 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: 05/06/2020

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
• Device Operator: No Information
• Device Model Number: N/A
• Device Catalogue Number: EDIV
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/20/2020
• Initial Date FDA Received: 05/07/2020
• 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