MAUDE Adverse Event Report: MECTA CORPORATION; ECT DEVICE

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

Patient Problems Memory Loss/Impairment (1958); Brain Injury (2219); Distress (2329)

Event Type  Injury  

Manufacturer Narrative

This is a law suit currently being adjudicated.It includes specific claims for three named plaintiffs.

Event Description

Law suit claiming neurocognitive injuries, memory loss, impaired visual and verbal memory, significant decline in ability to learn and recall information, disruption and decline in ability to encode new information, loss of executive function and additional physical and psychological harms.Patient 1 allegedly had 11 ect treatments for depression and anxiety.Patient 2 allegedly had 30 ect treatments for depression.Patient 3 allegedly had 36 ect treatments for depression.At this time, no other information is known.

• Type of Device: ECT DEVICE
• Manufacturer (Section D): MECTA CORPORATION; 19799 sw 95th avenue, suite b; tualatin, or
• Manufacturer (Section G): MECTA CORPORATION; 19799 sw 95th ave. suite b; tualatin, or
• Manufacturer Contact: robin nicol ; 19799 sw 95th ave., suite b; tualatin, or ; 6126780
• MDR Report Key: 10376716
• MDR Text Key: 202699406
• Report Number: 3020533-2020-00003
• Device Sequence Number: 1
• Product Code: GXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K965070
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2020
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability