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

Model Number	V.3.0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Headache (1880)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
She is having to spend time in bed due to head pain.Over the counter medications did not help so she is considering seeing a neurologist but has not yet.Complaint did not resolve as of (b)(6) 2026 when the report was made.The provider has been unable to get an update response from the patient as of (b)(6) 2026 when this report was submitted.
Event or Problem Description
A patient developed a severe, persistent headache that has now been present intermittently since (b)(6) 2026.

• Brand Name: NEUROSTAR ADVANCED THERAPY
• Common Device Name: TMS
• Manufacturer (Section D): NEURONETICS, INC.; 3222 phoenixville pike; malvern PA 32222
• 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: 24808663
• Report Number: 3004824012-2026-00013
• Device Sequence Number: 9548501
• Product Code: OBP
• UDI-Device Identifier: 00869378000117
• UDI-Public: 00869378000117
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 04/07/2026

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.3.0
• Device Catalogue Number: 81-02315-000
• 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: 03/09/2026
• Initial Report FDA Received Date: 04/07/2026
• 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: CRESTOR 20MG; PREGABALIN; SYNTHROID 100MCG
• Outcome Attributed to Adverse Event: Other
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Race: White