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

Model Number	NEUROSTAR 3.7
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	04/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A practice notified neuronetics on (b)(6) 2025 that a patient reported she had a seizure on (b)(6) 2025, at home, which occurred during her course of tms treatment.The patient was taken to er and released with no sequelae from the event but chose to discontinue tms therapy.
Additional Manufacturer Narrative
The patient was on two antidepressants that can lower a patient's seizure threshold.Based on the information available, it can not be ruled out that tms combined with the medications may have contributed to a seizure.

• 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: 22299358
• Report Number: 3004824012-2025-00033
• Device Sequence Number: 18299761
• Product Code: OBP
• UDI-Device Identifier: 00850005944829
• UDI-Public: 00850005944829
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2025

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
• Device Model Number: NEUROSTAR 3.7
• Device Catalogue Number: 81-04315-000
• 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: 05/22/2025
• Initial Report FDA Received Date: 06/20/2025
• 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: ESCITALOPRAM 10 MG; WELLBUTRIN
• Outcome Attributed to Adverse Event: Other
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White