MAUDE Adverse Event Report: TMS MACHINE; TRANSCRANIAL, MAGNETIC STIMULATOR

Device Problem Insufficient Information (3190)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/17/2019

Event Type  Injury  

Event Description

Acute onset suicidal ideation following tms procedure.Fda safety report id# (b)(4).

• Brand Name: TMS MACHINE
• Type of Device: TRANSCRANIAL, MAGNETIC STIMULATOR
• MDR Report Key: 8628595
• MDR Text Key: 145667820
• Report Number: MW5086798
• Device Sequence Number: 1
• Product Code: OBP
• 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: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 9 YR
• Patient Weight: 23