FDA Adverse Event Death Summary report: N

ECT DEVICE

MDR report key: 14288391 · Received May 4, 2022

Report

Report Number
MW5109519
Event Type
Death
Date Received
May 4, 2022
Report Date
May 2, 2022
Manufacturer
MECTA CORPORATION
Product Code
GXC
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
UK
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

PATIENT HAD THREE SESSIONS OF ECT ((B)(6) 2015, (B)(6) 2015 AND (B)(6) 2015) FOR A PSYCHIATRIC DIAGNOSIS OF DEPRESSIVE DISORDER OF A SEVERE DEGREE WITH A SUSPECTED UNDERLYING COGNITIVE IMPAIRMENT AND LEARNING DISABILITY. PATIENT DEVELOPED FOCAL SEIZURES AND STATUS ECLIPTICS, WHICH REQUIRED HER TRANSFER TO THE HIGH DEPENDENCY UNIT OF (B)(6) HOSPITAL AND THEN WAS DISCHARGED BACK TO THE WARD AT THE HOSPITAL ON (B)(6) 2015. BY (B)(6) 2015 PATIENT APPEARED TO DEVELOP ASPIRATION PNEUMONIA AND ALTHOUGH SHE WAS TREATED WITH ANTIBIOTICS, HER DECLINE CONTINUED AND SHE DIED ON (B)(6) 2015. POST-MORTEM EXAMINATION ON (B)(6) 2015 GAVE THE CAUSE OF DEATH AS 1A. ANOXIC-ISCHEMIC BRAIN DAMAGE DUE TO 1B STATUS EPILEPTICUS DUE TO 1C ELECTRO-CONVULSIVE THERAPY. FOR MORE INFORMATION PLEASE REFER TO THE ENTIRE REPORT TO PREVENT FUTURE DEATHS (B)(6). FDA SAFETY REPORT ID # (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1565585 ECT DEVICE DEVICE, ELECTROCONVULSIVE THERAPY GXC MECTA CORPORATION

Patients

Seq Age Sex Outcome Treatment
1 71 YR Unknown Other| D