MAUDE Adverse Event Report: ECT DEVICE; ELECTROCONVULSIVE THERAPY DEVICE FOR CATATONIA, MAJOR DEPRESSIVE DISORDER, AND B

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

Patient Problems Emotional Changes (1831); Speech Disorder (4415)

Event Type  Injury  

Event Description

In an effort to close the gap between community based outcomes and those acknowledged by the fda and disclosed to patients and their family members, i submit this report from information obtained from the (b)(6) on behalf of the doctors who have a responsibility as mandated reporters to disclose adverse events to the fda for tracking purposes to improve risks/warnings."early on in the ect course, (b)(6) did lose some language skills, he had garbled speech, and his personality became flat." fda safety report id# (b)(4).

• Brand Name: ECT DEVICE
• Type of Device: ELECTROCONVULSIVE THERAPY DEVICE FOR CATATONIA, MAJOR DEPRESSIVE DISORDER, AND B
• MDR Report Key: 15194041
• MDR Text Key: 297759907
• Report Number: MW5111390
• Device Sequence Number: 1
• Product Code: QGH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Other
• Patient Age: 24 YR
• Patient Sex: Male