MAUDE Adverse Event Report: NEURONETICS, INC. NEUROSTAR ADVANCED THERAPY SYSTEM; TRANSCRANIAL MAGNETIC STIMULATION

Model Number	NEUROSTAR 3.X
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Balance Problems (4401)
Date of Event	01/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient completed his course of tms treatment and saw improvement in his depression scores.The patient has pre-existing hand tremors and it is unknown if the balance issues are due to an underlying neurological disorder.The patient has a neurologist appointment booked in the near future.The information provided is inconclusive on how tms may have caused or contributed to the patient's symptoms.Due to the four falls the patient alleges, the company is reporting out of an abundance of caution.
Event or Problem Description
Patient reported having balance issues and falling 4 times over the past 30 days during tms treatment.The patient was not seriously injured during the falls, but balance issues continued throughout and after tms treatment.Patient is scheduled to see a neurologist in the near future.

• Brand Name: NEUROSTAR ADVANCED THERAPY SYSTEM
• Common Device Name: TRANSCRANIAL MAGNETIC STIMULATION
• 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: 21446161
• Report Number: 3004824012-2025-00003
• Device Sequence Number: 12592699
• Product Code: OBP
• UDI-Device Identifier: 00850005944430
• UDI-Public: 00850005944430
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K212289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 02/24/2025

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.X
• Device Catalogue Number: 81-02315-00R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 02/24/2025
• 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: OMEPRAZOLE 20MG 1 AT NIGHT; SERTRALINE 50MG 1/DAY
• Outcome Attributed to Adverse Event: Other
• Patient Age: 55 YR
• Patient Sex: Male