MAUDE Adverse Event Report: TRANSCRANIAL MAGNETIC STIMULATION; TRANSCRANIAL MAGNETIC STIMULATOR

Health Effect - Clinical Codes	Depression (2361); Sleep Dysfunction (2517)
Date of Event	06/21/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
I went through a full course of tms to improve depression.The tms treatment made my depression markedly worse and also gave me really bad insomnia.I was never told prior to starting this treatment that there were any negative side effects possible except headaches, administration site discomfort, and, in rare cases, seizures.This treatment/product should come with a warning that it may make your depression significantly worse and cause insomnia.

• Brand Name: TRANSCRANIAL MAGNETIC STIMULATION
• Common Device Name: TRANSCRANIAL MAGNETIC STIMULATOR
• MDR Report Key: 19618725
• Report Number: MW5156646
• Device Sequence Number: 16508548
• Product Code: OBP
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 06/22/2024

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
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2024
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 79 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White