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

Model Number	NEUROSTAR 3.0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Eye Pain (4467)
Date of Event	11/22/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Neuronetics was made aware by a tms practice that a male patient had eye pain and twitching that started about midway through his 36 treatment course and continues after treatment was completed.
Additional Manufacturer Narrative
Patient had neurological testing and opthomology appointment to determine cause of eye pain and twitching but results were normal.Some changes to the patient treatment settings, to address discomfort, are not considered normal protocol.The patient did finish the course of tms treatment and had improvement in his depression.A causal relationship between the patient's symptoms and the tms treatment can not be ruled out based on the existing information.Therefore, reporting out of an abundance of caution.

• Brand Name: NEUROSTAR ADVANCED THERAPY SYSTEM
• Common Device Name: TRANSCRANIAL MAGNETIC STIMULATION
• 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 ; 6109814027
• MDR Report Key: 21463043
• Report Number: 3004824012-2025-00005
• Device Sequence Number: 11615508
• Product Code: OBP
• UDI-Device Identifier: 00869378000117
• UDI-Public: 00869378000117
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/25/2025

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 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: 02/12/2025
• Initial Report FDA Received Date: 02/25/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 29 YR
• Patient Sex: Male