MAUDE Adverse Event Report: NEURONETICS, INC. NEUROSTAR; TMS

Model Number	NEUROSTAR TMS THERAPY SYSTEM 3.0
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Depression (2361); Suicidal Ideation (4429)
Date of Event	07/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided it can not be determined if neurostar treatment caused or contributed to the patient's symptoms.The treating physician stated that they did not think tms treatment was responsible for his suicidal ideation.
Event or Problem Description
Neuronetics recieved information from a practice that a patient was experiencing worsening depression, increased irritability, and suicidal ideation after treatment session number 8.The patient was hospitalized on (b)(6) 2025 for the suicidal ideation.

• Brand Name: NEUROSTAR
• 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: robin fatzinger ; 3222 phoenixville pike; malvern, PA 19355 ; 8776007555
• MDR Report Key: 22899690
• Report Number: 3004824012-2025-00044
• Device Sequence Number: 5828768
• Product Code: OBP
• UDI-Device Identifier: 00869378000117
• UDI-Public: 00869378000117
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K161519
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/26/2025

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: NEUROSTAR TMS THERAPY SYSTEM 3.0
• Device Catalogue Number: 81-02315-000
• 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: 08/01/2025
• Initial Report FDA Received Date: 08/26/2025
• 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: ADZENSYS 12.5MG; MIRTAZIPINE 7/5MG; PRISTIQ 150MG
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening
• Patient Age: 20 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White