MAUDE Adverse Event Report: SOMATICS, LLC SOMATICS, LLC; ELECTROCONVULSIVE THERAPY INSTRUMENT

Model Number N/A

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

Patient Problem Cognitive Changes (2551)

Event Type  Injury  

Event Description

(b)(6) claimed multiple injuries in a lawsuit filing.These included not warning her about brain damage, other cognitive effect.

• Brand Name: SOMATICS, LLC
• Type of Device: ELECTROCONVULSIVE THERAPY 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: 10466656
• MDR Text Key: 204880340
• Report Number: 1420295-2020-00011
• 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: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other