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

Model Number	NEUROSTAR ADVANCED THERAPY V 3.0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	08/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neuronetics received a call from a provider's office reporting one of their patients experienced a seizure about 4 minutes into her 9th treatment session.Patient initially began to experience right arm twitching when treatment began.Treatment was paused to adjust the coil in an attempt to alleviate the twitching.When treatment resumed, the patient stated that the arm twitch had started to become painful.Treatment was paused again to make further adjustments.As the session was paused, the patient began to seize and become stiff.The patient was reportedly unresponsive for about 90 seconds.Once the patient became verbally responsive, the provider called ems and patient was taken to the er.Patient has since expressed that she would like to continue with tms since the event but will be evaluated by a neurologist prior to a decision being made on whether to continue with treatment.The patient is on several medications that could impact her seizure threshold including wellbutrin, trintellix, and klonopin which could have contributed to the event.
Event or Problem Description
Neuronetics received a call from a treater reporting that one of their patients had experienced a seizure during her 9th treatment.The office contacted ems and the patient was then taken to the er.

• Brand Name: NEUROSTAR ADVANCED THERAPY
• Common Device Name: TRANSCRANIAL MAGNETIC 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 ; 6106404202
• MDR Report Key: 20192878
• Report Number: 3004824012-2024-00021
• Device Sequence Number: 7535453
• Product Code: OBP
• UDI-Device Identifier: 00869378000117
• UDI-Public: 00869378000117
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 09/12/2024

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: 08/28/2024
• Initial Report FDA Received Date: 09/11/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ALBUTEROL INHALER; KLONOPIN; TRINTELLIX 20 MG; WELLBUTRIN 300 MG
• Outcome Attributed to Adverse Event: Other
• Patient Age: 25 YR
• Patient Sex: Female
• Patient Weight: 64 KG