MAUDE Adverse Event Report: MECTA CORPORATION; ECT DEVICE

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  Injury  

Manufacturer Narrative

This is a class action law suit currently being adjucated.It includes specific claims for five named plaintiffs, and a list of other claims for unspecified complainants.

Event Description

Class action law suit claiming physiological, psychological and emotional injury in five patients.Patient (b)(6) allegedly had 6 ect treatments in (b)(6) for depression.Patient (b)(6) allegedly had over 20 ect treatments in (b)(6).Patient (b)(6) allegedly had over 58 ect treatments beginning in (b)(6) for her bipolar disorder.Patient (b)(6) allegedly had at least 7 ect treatment in (b)(6) for her major depressive disorder and severe anxiety.Patient (b)(6) allegedly had 22 ect treatments between (b)(6) for symptoms relating to withdrawal from psychotropic medication.Additional injury claims for the above 5 patients include: permanent brain damage, cognitive impairment, severe permanent retrograde and anterograde amnesia, and acute and/or chronic organic brain syndrome.Additional injury claims for unnamed patients include: "physiological, psychological and emotional trama including, but not limited to skin burns, permanent brain damage, severe permanent cognitive and memory impairment, broken teeth, prolonged seizures, myocardial infarction, ruptured bowels, acute and/or chronic organic brain syndrome, complete neurological collapse, and sometimes death, secondary to ect treatment." at this time, the patients' medical records have not been provided.After the medical records are provided, this information will be supplemented.

• Type of Device: ECT DEVICE
• Manufacturer (Section D): MECTA CORPORATION; 19799 sw 95th avenue, suite b; tualatin OR 97062
• Manufacturer (Section G): MECTA CORPORATION; 19799 sw 95th ave. suite b; tualatin OR 97062
• Manufacturer Contact: robin nicol ; 19799 sw 95th ave., suite b; tualatin, OR 97062 ; 5036126780
• MDR Report Key: 7294032
• MDR Text Key: 100894414
• Report Number: 3020533-2018-00011
• 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: Attorney
• Type of Report: Initial
• Report Date: 01/12/2018

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: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/20/2017
• Initial Date FDA Received: 02/23/2018
• 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