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

Model Number NEUROSTAR ADVANCED THERAPY V3.0

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

Patient Problem Convulsion/Seizure (4406)

Event Date 12/19/2023

Event Type  Injury  

Manufacturer Narrative

Neuronetics was contacted by a provider who reported that one of their patients had experienced a seizure about 8 minutes into their 2nd treatment session.Patient was monitored at the office after the seizure occurred and left the office with his mother.Per the provider, patient had recently started buproprion prior to beginning tms.Buproprion is known to potentially lower the seizure threshold in patients.Following the event, the provider decided to discontinue the patient's buproprion.The patient did not continue tms treatment.

Event Description

Neuronetics was contacted by a provider reporting that one of their patients had experienced a seizure during their 2nd treatment session.

• Brand Name: NEUROSTAR ADVANCED THERAPY
• Type of Device: TRANSCRANIAL MAGNETIC STIMULATOR
• Manufacturer (Section D): NEURONETICS, INC.; 3222 phoenixville pike; malvern PA 19355
• Manufacturer (Section G): NEURONETICS, INC.; 3222 phoenixville pike; malvern PA 19355
• Manufacturer Contact: anna gorbunov ; 3222 phoenixville pike; malvern, PA 19355 ; 6106404202
• MDR Report Key: 18525091
• MDR Text Key: 333024812
• Report Number: 3004824012-2024-00003
• Device Sequence Number: 1
• Product Code: OBP
• UDI-Device Identifier: 00869378000117
• UDI-Public: 00869378000117
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/17/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: NEUROSTAR ADVANCED THERAPY V3.0
• Device Catalogue Number: 81-02315-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: BUPROPRION 150 MG DAILY.; BUSPIRONE 15 MG DAILY.; L-GLUTAMINE 500 MG TWICE A DAY.; L-METHYLFOLATE 15 MG DAILY.; LAMOTRIGINE 150 MG DAILY.; VITAMIN D3.; VRAYLAR 1.5 MG DAILY.
• Patient Outcome(s): Other
• Patient Age: 19 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White