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

Model Number	NEUROSTAR ADVANCED THERAPY SYSTEM V3.0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	05/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neurometrics received a call from a provider reporting one of their patients had a seizure during their first treatment session.Patient had his motor threshold determined same day.Within 5 minutes of beginning his first treatment session, patient reportedly began to have a panic attack and treatment was paused.The patient then reportedly experienced a sudden change in mental status, his "eye gazed to the right", and had "tonic-clonic movement of his right arm only" which lasted 60-90 seconds.Ems was called and patient was taken to the emergency room.Emergency room report was unremarkable but patient will not continue with tms treatment.It was noted that the patient had a history of a motor vehicle accident which may have resulted in a possible head injury which could impact the patient's seizure threshold.
Event or Problem Description
Neurometrics received a call from a provider's office reporting one of their patients experienced a seizure during their first treatment session.Following the event, patient was taken to the emergency room.

• Brand Name: NEUROSTAR ADVANCED THERAPY SYSTEM
• Common Device Name: 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
• MDR Report Key: 19511417
• Report Number: 3004824012-2024-00015
• Device Sequence Number: 12637043
• Product Code: OBP
• UDI-Device Identifier: 00869378000117
• UDI-Public: 00869378000117
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K201158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2024

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
• Operator of Device: Health Professional
• Device Model Number: NEUROSTAR ADVANCED THERAPY SYSTEM V3.0
• Device Catalogue Number: 81-01335-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASPIRIN; CRESTOR 20 MG; DOXYCYCLINE 100 MG; HYDROCORTISONE 1%; LENVIMA 20 MG; METRONIDAZOLE 0.75%; VITAMIN B12; VITAMIN D3; XANAX 0.5 MG 1T PO BID PRN ANXIETY OR SLEEP
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 79 KG
• Patient Race: White