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); Depression (2361)

Event Date 01/09/2000

Event Type  Injury  

Manufacturer Narrative

No possible follow up on the injury.

Event Description

Patient experienced severe memory loss after receiving ect treatments in year (b)(6).

• Type of Device: ECT DEVICE
• Manufacturer (Section D): MECTA CORPORATION; 19799 sw 95th ave. 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: 7294043
• MDR Text Key: 100888706
• Report Number: 3020533-2018-00002
• 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

• Date FDA Received: 02/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2007
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability