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

Model Number	N/A
Health Effect - Clinical Code	Injury (2348)
Date of Event	07/26/2010
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
Many serious injuries were claimed.

• Brand Name: SOMATICS ECT INSTRUMENT
• Common Device Name: THYMATRON
• Manufacturer (Section D): SOMATICS, LLC; 720 commerce drive; suite 101; venice, fl
• MDR Report Key: 10032208
• Report Number: 1420295-2020-00006
• Device Sequence Number: 3116672
• Product Code: GXC
• UDI-Device Identifier: 00850298007003
• UDI-Public: 00850298007003
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: 945120
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Model Number: N/A
• Device Catalogue Number: EDIV
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/20/2020
• Initial Report FDA Received Date: 05/07/2020
• 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: Other