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

Model Number	NEUROSTAR 3.0
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Balance Problems (4401); Speech Disorder (4415)
Date of Event	04/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient alleges that tms treatment has affected her walking and caused her to stutter which negatively impacts her ability to work.
Additional Manufacturer Narrative
The practice notes indicated that the patient used a cane prior to the start of tms and did not notice a persistent stutter.These adverse events are not known to be associated with tms treatment and a conclusion about the relatedness can not be made based on the information provided.

• 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: 22082671
• Report Number: 3004824012-2025-00025
• Device Sequence Number: 12768132
• Product Code: OBP
• UDI-Device Identifier: 00869378000117
• UDI-Public: 00869378000117
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/25/2025

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 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: 04/25/2025
• Initial Report FDA Received Date: 05/25/2025
• 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: ALIGN.; CREON 36000IU.; EFFEXOR 150MG.; FENTANYL PATCH 37.5MCG ON PATCH EVERY THREE DAYS.; HYDROXYZINE 10MG.; IRON INFUSIONS 2 X YEARLY.; LINZES.; MAGNESIUM DROPS.; PERCOCET.; PICC LINE IN PLACE.; PROZAC 60MG.; TRAZADONE 50MG.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 54 YR
• Patient Sex: Female