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

Model Number	NEUROSTAR 2.0
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	03/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient was taking three medications that can lower seizure threshold.Based on the information available, it can not be ruled out that tms combined with the medications may have contributed to seizures.
Event or Problem Description
Neuronetics received a call from a former tms patient that alleges she started having seizures about 5 months (march 2025) after her treatment ended in october of 2024.She stated her first episodes required hospitalization for 3 days.
Additional Manufacturer Narrative
Supplement 01 with corrected device model number, serial number, udi number and premarket submission number.

• 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: 22366455
• Report Number: 3004824012-2025-00038
• Device Sequence Number: 9582269
• Product Code: OBP
• UDI-Device Identifier: 00869378000100
• UDI-Public: 00869378000100
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: DEN070003
• 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,Followup
• Report Date (Section B): 07/14/2025

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 2.0
• Device Catalogue Number: 81-01315-000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 07/14/2025
• 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: ABILIFY 2 MG.; ADDERALL 30 MG.; FLUOXETINE HYDROCHLORIDE 40MG.; XANAX 1MG.; ZALEPLON 10MG.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 38 YR
• Patient Sex: Female