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

Model Number	V.3.0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	01/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient had received 28 treatments for depression (mdd) and 26 for ocd.Patient's family had come to town to check on them and had given an ultimatum of going into an intensive outpatient program or they would be cut off financially.The patient did not show up for the monday morning tms appointment, and the father notified the practice that the patient had attempted suicide.The patient stayed in the hospital for a week, is now physically okay, and entered an intensive outpatient progrram.Prior to tms, the patient had suicidal ideation without a plan and did not communicate otherwise during her course of treatment.The patient's phq9 prior to tms was already the maximum score and indicating suicidal ideation.The score decreased but went back to the maximum score right before attempting suicide.It is unclear whether tms caused or contributed to the attempted suicide since other factors were present as well.
Event or Problem Description
Patient attempted suicide in their home.The practice noted that the patient had worsening anxiety, ocd, and sucidal ideation prior to the attempt, but their last depression scores did not worsen above their baseline score.

• 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, NC 19355 ; 8776007555
• MDR Report Key: 24298899
• Report Number: 3004824012-2026-00004
• Device Sequence Number: 10381964
• Product Code: OBP
• UDI-Device Identifier: 00869378000117
• UDI-Public: 00869378000117
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/09/2026

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.3.0
• Device Catalogue Number: 81-02315-000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 02/09/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CLONIDINE 0.1MG.; PRISTIQ 50MG.; SEROQUEL 25MG.; VRAYLAR 3MG.
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 21 YR
• Patient Sex: Female
• Patient Race: White