MAUDE Adverse Event Report: Neuronetics, Inc NeuroStar Advanced Therapy; TMS

Model Number	v3.8
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	08/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Tms patient experienced a seizure during a tms treatment.
Additional Manufacturer Narrative
Before starting treatment on the day of the event, the patient noted that they were feeling off.Treatment was being delivered that day for tms, although no specific correlation was determined, it occurred while in the neurostar chair.The patient did end up having a medical history of multiple seizures related to alcohol withdrawal in early (b)(6) 2026, also recent information from the post-seizure er visit showed there is history of subarachnoid hemorrhage and subdural hematoma.These conditions could have contributed to the seizure, and the provider noted that it was possible that the patient's medical history contributed to the seizure.Patient does not have any sequelae related to the seizure.

• Brand Name: NeuroStar Advanced Therapy
• Common Device Name: TMS
• Manufacturer (Section D): Neuronetics, Inc; 3222 phoenixville pike; malvern PA 19355
• Manufacturer (Section G): Neuronetics, Inc.; 3222 phoenixville pike; malvern PA 19355
• Manufacturer Contact: nadine lievenbruck ; 3222 phoenixville pike; malvern, PA 18355 ; +1(877)600-7555
• MDR Report Key: 50813221
• Report Number: 3004824012-2026-00021
• Device Sequence Number: 10696968
• Product Code: OBP
• UDI-Device Identifier: 00850005944621
• UDI-Public: 00850005944621
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K233621
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: v3.8
• Device Catalogue Number: 81-05315-000
• 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: 08/21/2026
• Initial Report FDA Received Date: 09/18/2026
• 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: Fluoxetine 40mg daily; Folic acid 1 mg daily; hydroxyzine 25mg, 1/2 to 2 tabs tid prn; mirtazapine 25mg 102 tabs bedtime prn; multivitamin 1 daily; nicotine patch 1 daily; thiamine 100mg daily
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Race: White