MAUDE Adverse Event Report: NEURONETICS, INC NEUROSTAR ADVANCED THERAPY; TMS

Model Number	V.3.7
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Emotional Changes (1831); Tics/Tremor (4425)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neuronetics' social media monitor reached out to the person who posted the alleged adverse event.However the person did not respond to the request.Neuronetics was able to determine the practice that provide tms treatment.The clinic confirmed that the patient had an increase in anxiety/panic attacks but there was no note about tics occurring.
Event or Problem Description
Patient commented on a nni social media ad that he experienced increased anxiety and tics due to tms treatment after the first week of treatment.

• Brand Name: NEUROSTAR ADVANCED THERAPY
• Common Device Name: TMS
• Manufacturer (Section D): NEURONETICS, INC; 3222phoenixville 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 ; 8776007555
• MDR Report Key: 23623996
• Report Number: 3004824012-2025-00059
• Device Sequence Number: 8968870
• Product Code: OBP
• UDI-Device Identifier: 00850005944522
• UDI-Public: 00850005944522
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Consumer,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/21/2025

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.3.7
• Device Catalogue Number: 81-04315-000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (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: 61 YR
• Patient Sex: Male
• Patient Weight: 181 KG