MAUDE Adverse Event Report: NEURONETICS, INC NEUROSTAR ADVANCED THERAPY; TMS

Model Number	V.3.8
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	12/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient experienced a seizure during her 14th tms treatment.She had received 27 minutes/ 2400 pulses when seizure activity was noticed.Treatment stopped and ems called.
Additional Manufacturer Narrative
Patient was not treated with the full treatment dose percentage for the protocol.Patient has a history of seizures as a child which was not properly disclosed, and she had not been sleeping well prior the seizure which could contribute to the seizure risk.Patient on two medications that could affect seizure threshold if not taken as scheduled, but it is not known whether the patient missed any doses.

• Brand Name: NEUROSTAR ADVANCED THERAPY
• 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: nadine lievenbruck ; 3222 phoenixville pike; malvern, PA 19355 ; 8776007555
• MDR Report Key: 23977211
• Report Number: 3004824012-2026-00001
• Device Sequence Number: 16131694
• Product Code: OBP
• UDI-Device Identifier: 00850005944621
• UDI-Public: 00850005944621
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K233621
• 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): 01/06/2026

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: V.3.8
• Device Catalogue Number: 81-05315-000
• 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: 12/10/2025
• Initial Report FDA Received Date: 01/06/2026
• 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 0.25 MG; CARTIA XT 180 MG; PANTOPRAZOLE 40MG; VENLAFAXINE ER 37.5MG; ZOLPIDEM 5MG
• Outcome Attributed to Adverse Event: Other
• Patient Age: 29 YR
• Patient Sex: Female
• Patient Race: White