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

Model Number	NEUROSTAR TMS THERAPY SYSTEM 3.7
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Depression (2361); Sleep Dysfunction (2517)
Date of Event	06/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient did respond to questions from neuronetics and reported that the insomnia has improved somewhat since making the medwatch report.He has difficulty staying asleep even with the medication and gets about 4-6 hours of sleep/night.He did indicate that he has always had sleep difficulty which may be related to his adhd and/or chronic internet addiction.
Event or Problem Description
Neuronetics received a medwatch from fda (mw5173067) alleging that neurostar tms treatment resulted in worsening depression and persistent insomnia after 1.5 weeks of treatment.

• 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: 22919321
• Report Number: 3004824012-2025-00045
• Device Sequence Number: 9676611
• Product Code: OBP
• UDI-Device Identifier: 00850005944522
• UDI-Public: 00850005944522
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/28/2025

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 3.7
• Device Catalogue Number: 81-04315-000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 08/28/2025
• 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: MELATONIN SUPPLEMENT (5-15MG).; ROZEREM (8-16MG) POST TMS.; TRAZADONE (25-50MG).; ZOLOFT (25MG).; ZYRTEC.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White