MAUDE Adverse Event Report: NEURONETICS, INC. NEUROSTAR ADVANCED THERAPY; TRANSCRANIAL MAGNETIC STIMULATOR

Model Number	NEUROSTAR ADVANCED THERAPY V3.7
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Suicidal Ideation (4429)
Date of Event	11/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A provider contacted neuronetics to report that they had learned that one of their past patients had attempted suicide and has been hospitalized.The provider was informed of this from the patient's treating psychiatrist.The event occured over a month after patient had finished her course of tms.Patient had reportedly experienced a family tragedy during her course of treatment.Per the provider, patient had been getting better throughout treatment but this event had "derailed" the patient's progress and the provider had decided to extend her treatment course as a response.Patient had reportedly been having general suicidal ideation prior to starting tms and her phq-9 scores indicated that she had been experiencing suicidal ideation during treatment as well.Neuronetics has been unable to obtain further information from the patient's treating psychiatrist to determine what had led to the event and if the patient has had a prior history of suicide attempts.Neuronetics is unable to determine the exact cause of the event and is reporting out of an abundance of caution.
Event or Problem Description
Neuronetics received a call from a provider reporting that one of their patients attempted suicide over a month after finishing her tms treatment course and was subsequently hospitalized.

• Brand Name: NEUROSTAR ADVANCED THERAPY
• Common Device Name: TRANSCRANIAL MAGNETIC STIMULATOR
• Manufacturer (Section D): NEURONETICS, INC.; 3222 phoenixville pike; malvern PA 19355
• Manufacturer (Section G): NEURONETICS, INC.; 3222 phoenixville pike; malvern PA 19355
• Manufacturer Contact: anna gorbunov ; 3222 phoenixville pike; malvern, PA 19355 ; 6106404202
• MDR Report Key: 18438485
• Report Number: 3004824012-2024-00001
• Device Sequence Number: 20591596
• Product Code: OBP
• UDI-Device Identifier: 00850005944522
• UDI-Public: 00850005944522
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K230029
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/03/2024

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 ADVANCED THERAPY V3.7
• Device Catalogue Number: 81-04335-000
• 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: 12/08/2023
• Initial Report FDA Received Date: 01/03/2024
• 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: ALPRAZOLAM 2 MG; CLONIDINE 2 MG; FLUOXETINE 90 MG; SUBOXONE 8 MG; ZOLPIDEM 10 MG
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 79 KG