MAUDE Adverse Event Report: NEURONETICS, INC. NEUROSTAR ADVANCED THERAPY; TRANSCRANIAL MANGETIC STIMULATOR

Model Number	NEUROSTAR ADVANCED THERAPY V 3.0
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Transient Ischemic Attack (2109)
Date of Event	08/19/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Neuronetics was contacted by a provider who called to ask whether a patient who experienced a tia could continue treatment.On the day of his 31st treatment session, the patient was in a car accident that morning but had come in for treatment.Later that same evening, the patient had a tia.
Additional Manufacturer Narrative
Neuronetics was contacted by a provider who was asking if they could continue to treat a patient who experienced a tia during his course of tms treatment.On the day of the event, patient had experienced a car accident in the morning.The patient later went to his tms appointment and received his 31st treatment session.Later that same night, patient went to the er after noticing arm weakness and was diagnosed with a tia.A ct scan was taken and it was noted he had several clogged arteries but no evidence of a brain bleed.At the time of the patient's tms treatment, patient was reportedly walking fine and did not appear to be injured.Patient is reportedly doing well and wishes to continue with tms.Neuronetics has attempted to obtain additional information on the patient and the complaint but has been unsuccessful.Neuronetics is unable to determine the cause of the event due to the information that is currently available and is reporting out of an abundance of caution due to the serious nature of the event.

• Brand Name: NEUROSTAR ADVANCED THERAPY
• Common Device Name: TRANSCRANIAL MANGETIC STIMULATOR
• Manufacturer (Section D): NEURONETICS, INC.; 3222 phoenixville pike; malvern PA 19355
• Manufacturer (Section G): NEURONETICS, INC.; 3222 phoenixville pike; malvern PA 19355
• Manufacturer Contact: anna gorbunov ; 3222 phoenixville pike; malvern, PA 19355
• MDR Report Key: 20257659
• Report Number: 3004824012-2024-00022
• Device Sequence Number: 8013145
• Product Code: OBP
• UDI-Device Identifier: 00869378000117
• UDI-Public: 00869378000117
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K201158
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2024

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 ADVANCED THERAPY 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: 08/22/2024
• Initial Report FDA Received Date: 09/19/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown