MAUDE Adverse Event Report: MECTA CORPORATION SPECTRUM

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

Patient Problems Memory Loss/Impairment (1958); Cognitive Changes (2551)

Event Date 05/11/2018

Event Type  Injury  

Event Description

Approximately 3 years after receiving a series of electroconvulsive therapy treatments, patient claims the following: not warned of risks of permanent memory loss, brain injury, and neurocognitive injury; developed permanent memory and cognitive impairments as well as delayed reactions, rather than improving.

• Brand Name: SPECTRUM
• Type of Device: SPECTRUM
• 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: 12154550
• MDR Text Key: 261198026
• Report Number: 3020533-2021-00006
• 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: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Date Manufacturer Received: 06/24/2021
• 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): Disability