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

Model Number	NEUROSTAR 3.8
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Headache (1880)
Date of Event	08/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Neuronetics received information from a practice regarding a patient that started having persistent migraines after tms treatment number 17, the patient went to the er twice due to the migraines but they were unable to determine the cause or rule out tms as the cause and referred her to a neurologist.The patient reports not being able to work as a result of the migraines.
Additional Manufacturer Narrative
During the patient's er visits, they could not rule out tms as a cause for her migraines, however the patient has continued tms treatment since her depression has improved.

• Brand Name: NEUROSTAR ADVANCED THERAPY SYSTEM
• 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: 23068892
• Report Number: 3004824012-2025-00055
• Device Sequence Number: 9663371
• Product Code: OBP
• UDI-Device Identifier: 00850005944621
• UDI-Public: 00850005944621
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/16/2025

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 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: 08/18/2025
• Initial Report FDA Received Date: 09/16/2025
• 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: DEPO-TESTOSTERONE 200MG/ML INJECTION; TYLENOL PRM; ZOFRAN PRN
• Outcome Attributed to Adverse Event: Other
• Patient Age: 26 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American