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

Model Number	NEUROSTAR TMS THERAPY SYSTEM 3.0
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Headache (1880); Tics/Tremor (4425)
Date of Event	09/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient did respond to questions from neuronetics and reported that the migraines have reduced in frequency.She completed her degree and is currently working.Based on the information provided, no conclusion can be made on how tms may have caused or contributed to the patient's migraines.During communication with the patient, she did state that the tics were most likely due to the medication she was taking at the time of tms treatment.
Event or Problem Description
Neuronetics received a medwatch from fda (mw5172397) alleging that a patient received tms (neurostar) treatment in 2023 resulted in recurring, unilateral migraines on the same side that she was treated with tms.Additionally, the patient alleges that she has a tic on the left side of her face, which is a common side-effect of a drug she was taking at the time of her tms treatment.However, after stopping the drug, the tic remained.The reporter states that she "can't confidently attribute all the migraines to tms." and there is no information that she has received a diagnosis from a neurologist.

• 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 ; 8776007555
• MDR Report Key: 22865918
• Report Number: 3004824012-2025-00043
• Device Sequence Number: 7631948
• Product Code: OBP
• UDI-Device Identifier: 00869378000117
• UDI-Public: 00869378000117
• Combination Product (Y/N): N
• Initial Reporter State: NV
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/21/2025

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 TMS THERAPY SYSTEM 3.0
• Device Catalogue Number: 81-02315-000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 08/21/2025
• 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: ABILIFY (15MG).; APLENZIN (522 MG).; VYVANSE (30MG).
• Outcome Attributed to Adverse Event: Other
• Patient Age: 25 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White