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

Model Number	V.3.8
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	02/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient experienced a seizure during her 30th daily treatment after receiving 1,907 pulses.Patient was treated by ems and taken to the er in stable condition.
Additional Manufacturer Narrative
Provider attributes to medication non-compliance issue: patient reportedly ran out of venlafaxine, did not inform prescribing provider or tms staff at first, then may have resumed medication without discussing with prescribing provider.Patient is not continuing tms as their depression scores are hovering around remission.Patient will be seen by a neurologist.

• Brand Name: NEUROSTAR ADVANCED THERAPY
• Common Device Name: TMS
• Manufacturer (Section D): NEURONETICS, INC.; 3222 phoenexville pike; malvern PA 19355
• Manufacturer (Section G): NEURONETICS, INC; 3222phoenixville pike; malvern PA 19355
• Manufacturer Contact: nadine lievenbruck ; 3222 phoenixville pike; malvern, PA 19355 ; 8776007555
• MDR Report Key: 24503866
• Report Number: 3004824012-2026-00008
• Device Sequence Number: 9943484
• Product Code: OBP
• UDI-Device Identifier: 00850005944621
• UDI-Public: 00850005944621
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

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: Not provided
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (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: ESTRADIAL 10MCG.; FLUCONAZOLE 150MG AGAIN FOR 7 DAYS START (B)(6) 2026.; FLUCONAZOLE 150MG FOR 4 DAYS START (B)(6) 2025.; HYDROXYZINE 10MG AS NEEDED.; IRON 10MCG (2) TABLETS (L LOEST ONE) IN MORNING.; IRON PILL 65MG AT NIGHT.; IVABRADINE 5MG IN MORNING AND AT NIGHT.; LAMOTRIGINE 200MG TABLET DAILY.; LEVOTHYROXINE (INCREASED FROM 100MCG TO 112 MCG).; METFORMIN ER 500 MG TABLET BY MOUTH DAILY.; NORETHINDRONE 1MG.; VENLAFAXINE ER 37.5 MG CAPSULE.; VENLAFAXINE HCL ER 150MG ONE CAPSULE AT NIGHT.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 20 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White