MAUDE Adverse Event Report: TRANSCRANIAL MAGNETIC STIMULATOR; MERT

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

Patient Problem Emotional Changes (1831)

Event Date 12/14/2020

Event Type  Injury  

Event Description

Mert tms treatment; i had one treatment and afterwards i had a hard time figuring out if i want to walk into the other room or why i walked into another room or what i am doing i had zero motivation.I feel like a vegetable and i woke up the next morning and started crying several times without any significant emotion i rarely cry.Brain fog.Fda safety report id # (b)(4).

• Brand Name: TRANSCRANIAL MAGNETIC STIMULATOR
• Type of Device: MERT
• MDR Report Key: 11125325
• MDR Text Key: 225573878
• Report Number: MW5098697
• Device Sequence Number: 1
• Product Code: QCI
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/02/2021

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/05/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 54 YR
• Patient Weight: 52