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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Brain Injury (2219)

Event Date 08/02/2022

Event Type  Injury  

Event Description

Diagnosed with traumatic brain injury after completing 20 sessions of transcranial magnetic stimulation indicated for major depressive disorder.Comprehensive three hour assessment consisting of multiple tests and questions.Fda safety report id# (b)(4).

• Brand Name: NEURONETICS TMS
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATOR
• Manufacturer (Section D): NEURONETICS INC.
• MDR Report Key: 15380692
• MDR Text Key: 299702397
• Report Number: MW5111931
• 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: Patient
• Type of Report: Initial
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 28 YR
• Patient Sex: Male
• Patient Weight: 102 KG
• Patient Race: White