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

Model Number	v.3.8
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Type of Reportable Event	Serious Injury
Event or Problem Description
Dr.(b)(6) called into neuronetics, inc.To report that a patient experienced a seizure during tms treatment a few weeks ago.No information was provided.
Additional Manufacturer Narrative
Tms provider called into neuronetics (nni) customer support to report that a patient experienced a seizure during tms treatment a few weeks prior.No information was initially provided.They asked that a medical form be faxed to a number, but this was not an option, and no follow up phone number was provided.The medical affairs manager was able to connect with the clinical operations manager (b)(6) at the practice and emailed the medical complaint form to him and to the general assistant email.Contact was attempted 3+ times after the initial phone call.The practice did not provide any patient or incident details.Neuronetics is unable to verify any details surrounding the seizure (treatment #, medications and any changes, any outside factors, contributing factors, medical history, etc.).

• 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 19355 ; +1(877)600-7555
• MDR Report Key: 50546069
• Report Number: 3004824012-2026-00020
• Device Sequence Number: 13341724
• Product Code: OBP
• UDI-Device Identifier: 00850005944621
• UDI-Public: 00850005944621
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

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: v.3.8
• 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: 08/03/2026
• Initial Report FDA Received Date: 09/01/2026
• 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 Sex: Unknown