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

Model Number	81-02315-000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Headache (1880); Memory Loss/Impairment (1958); Dizziness (2194); Depression (2361); Sleep Dysfunction (2517); Cognitive Changes (2551); Unspecified Nervous System Problem (4426); Hallucination (4428); Unspecified Mental, Emotional or Behavioural Problem (4430); Unspecified Gastrointestinal Problem (4491)
Date of Event	02/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient nightmares have improved.However, she is still having worsened hallucinations and has chosen to stop driving for now since she is afraid that things are going to hurt her.She is still experiencing worsened depression, increased lack of motivation, and increased headaches, she was referred to neurology for the heavy tongue, confusion, being more forgetful, vivid nightmares, and sleep paralysis but has not yet had an appointment.Her pcp ordered head and chest x-rays but the results are not back yet.The relationship of tms to all of her complaints is unclear.Tms is not cleared by the fda for patients who have psychotic features.
Event or Problem Description
A practice reported that a current tms patient presented for treatment stating that she was experiencing nightmares, vision distortion, seeing objects that aren't there, and loud noises becoming bothersome.She wanted to know if these things were common side effects, which they are not.

• 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: 24680807
• Report Number: 3004824012-2026-00011
• Device Sequence Number: 15879573
• Product Code: OBP
• UDI-Device Identifier: 00869378000117
• UDI-Public: 00869378000117
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/24/2026

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: 81-02315-000
• Device Catalogue Number: V.3.0
• 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: 02/25/2026
• Initial Report FDA Received Date: 03/24/2026
• 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: ARIPIPRAZOLE; DOXEPIN; SERTRALINE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Hispanic