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

Model Number	NEUROSTAR 3.7
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	10/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient initially had 11 tms treatments on a magstim device and then was switched to a neurostar device for the following 22 treatment sessions.The patient mentioned that she had not had any food or water before her treatment.She also did not have her usual caffeine the morning of the seizure.The patient later informed the provider that she was newly pregnant and decided to discontinue treatment.The provider stated that potential dehydration and recent completion of amoxicillin on (b)(6) 2024 may have contributed to the seizure.Please note that this is being submitted late after a review of the file revealed that a supplement to the initial filing in 2024 was not successful.The original form had a typo and failed submission so a supplement was filed to correct the mdr numbering typo.Acknowledgements were received but it was not noted that there was another failure until (b)(6) 2025.
Event or Problem Description
Practice called neuronetics to report that patient had a seizure during treatment.Patient refused medical attention, the seizure self-resolved, and they reported feeling fine following the event.

• 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: 22367274
• Report Number: 3004824012-2024-00025
• Device Sequence Number: 11859336
• Product Code: OBP
• UDI-Device Identifier: 00850005944522
• UDI-Public: 00850005944522
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K230029
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/30/2025

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 3.7
• Device Catalogue Number: 81-04315-000
• 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: 10/21/2024
• Initial Report FDA Received Date: 06/30/2025
• 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: AMOXICILLIN
• Outcome Attributed to Adverse Event: Other
• Patient Age: 25 YR
• Patient Sex: Female