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

Model Number	NEUROSTAR ADVANCED THERAPY 3.8
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Emotional Changes (1831)
Date of Event	04/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The treating physician noted that there was a medication change during the patient's treatment which may have contributed to the increased anxiety.
Event or Problem Description
A practice notified neuronetics that a patient experienced worsening anxiety and resurfacing of ptsd in her dreams after starting tms treatment.She stopped after 7 treatments.

• 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 ; 6109814027
• MDR Report Key: 22036150
• Report Number: 3004824012-2025-00013
• Device Sequence Number: 8177894
• Product Code: OBP
• UDI-Device Identifier: 00850005944621
• UDI-Public: 00850005944621
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 05/16/2025

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
• Operator of Device: Health Professional
• Device Model Number: NEUROSTAR ADVANCED THERAPY 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: 04/18/2025
• Initial Report FDA Received Date: 05/16/2025
• 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: DIAZEPAM 5MG; FLUVOXAMINE 50 MG; GUANFACINE 2MG
• Outcome Attributed to Adverse Event: Other
• Patient Age: 37 YR
• Patient Sex: Female