MAUDE Adverse Event Report: NEURONETICS INC. NEUROSTAR; TRANSCRANIAL MAGNETIC STIMULATOR

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

Patient Problem Emotional Changes (1831)

Event Date 01/11/2021

Event Type  Injury  

Event Description

Panic attack symptoms; i was undergoing tms treatment when i experienced a panic attack during 1 session on january 11th.It happened at the start of a new session and did not end for over 2 weeks.Fda safety report id# (b)(4).

• Brand Name: NEUROSTAR
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATOR
• Manufacturer (Section D): NEURONETICS INC.
• MDR Report Key: 11272342
• MDR Text Key: 230327408
• Report Number: MW5099153
• Device Sequence Number: 1
• Product Code: QCI
• 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: 01/29/2021

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: 02/02/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 38 YR
• Patient Weight: 82