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	08/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient experienced a seizure while receiving their 27th daily ocd tms treatment which was part of a composite treatment (mdd (theta burst) and ocd).
Additional Manufacturer Narrative
Patient had been receiving itbs (touchstar theta burst treatment for mdd) and ocd as a combined daily treatment for 26 treatments without issue.On their 27th out of 29 treatments for ocd, the patient received their full touchstar treatment (theta burst treatment) and only received 80 pulses with the ocd protocol before having a seizure during treatment.The patient has stopped tms and is waiting for an appointment with neurology.No specific underlying factors have been identified for the cause of tms and have not confirmed the specific causal relationship with tms, but it did occur during the actual daily treatment for ocd.

• 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 85234 ; +1(877)600-7555
• MDR Report Key: 50915154
• Report Number: 3004824012-2026-00022
• Device Sequence Number: 5394043
• Product Code: QCI
• UDI-Device Identifier: 00850005944621
• UDI-Public: 00850005944621
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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 Practitioner
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 08/31/2026
• Initial Report FDA Received Date: 09/28/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 18 YR
• Patient Sex: Female
• Patient Weight: 185 LB