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

Model Number	NEUROSTAR 2.4
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Headache (1880)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This adverse event is submitted to the agency late as a corrective action since it was determined to be reportable after an audit of the company's complaint database.
Event or Problem Description
Pt.Experience head pain and eyelid droop after 2nd tx.Treating physician sent patient to er upon arrival to 3rd tx.Pt.Was subjected to a ct scan (and associated risks which otherwise may not have required).Pt.Diagnosed with complex migraines.Can not rule out that tms may have contributed to the condition and requirement of diagnostic tx.Submitting out of an abundance of caution.

• 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: 22074764
• Report Number: 3004824012-2025-00023
• Device Sequence Number: 8530883
• Product Code: OBP
• UDI-Device Identifier: 00850005944423
• UDI-Public: 00850005944423
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K160703
• 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): 05/23/2025

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
• Device Model Number: NEUROSTAR 2.4
• Device Catalogue Number: 81-01315-00R
• 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: 01/17/2018
• Initial Report FDA Received Date: 05/22/2025
• 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 5MG HS.; BUSPIRONE 20MG TID.; HYDROXYZINE 50MG UP TO QID.; REMERON 30MG HS.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR
• Patient Sex: Female