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

Model Number	V.3.7
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Suicidal Ideation (4429)
Date of Event	12/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient is autistic and has a history of self-harm including a previous suicide attempt in 2023.
Event or Problem Description
The patient's mother notified the tms provider's practice that her son (patient) had inflicted self-harm by taking too many pills from his medication.Patient's mother did not refer to it as a suicide attempt but referred to as self-harm.Patient was taken to the er and then admitted to 7 days of inpatient treatment.

• 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 ; 8776007555
• MDR Report Key: 24385199
• Report Number: 3004824012-2026-00007
• Device Sequence Number: 13403733
• Product Code: OBP
• UDI-Device Identifier: 00850005944522
• UDI-Public: 00850005944522
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/18/2026

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.3.7
• Device Catalogue Number: 81-04315-000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 02/18/2026
• 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: CLOMIPRAMINE 200MG; DEPAKOTE 50MG BID
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 18 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian