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

Model Number	VERSION 3.6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	10/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Neuronetics was contacted by a provider reporting that one of their patients had a seizure after completing his first theta burst treatment session.Ems was called and the patient was sent to the emergency room.
Additional Manufacturer Narrative
Neuronetics received a call from a provider reporting that one of their patients had a seizure after completing their first theta burst session.Patient was mapped on the same day and provider reported that patient had a "tough mapping" where it was difficult to locate the patient's thumb movement.During the treatment session patient did report that the pulsing felt uncomfortable but otherwise tolerated treatment well.Toward the end of the treatment, patient noted that he was experiencing "shortness of breath".After the treatment was finished, patient was getting up from the chair and had a seizure that lasted about 15-30 seconds.Patient reportedly recovered very quickly at the office with no memory loss but ems was called and patient was sent to the emergency room as a precaution.Patient was discharged from the emergency room within an hour.Patient is currently on several medications that could potentially impact his seizure threshold including abilify, trileptal, and spravato since july of this year.The provider reported that the patient's last dose of spravato was the day before he received his first treatment session.Provider also noted that the patient is "restless" at night often waking up "with the bed torn" but is reportedly able to sleep through the night.The provider wants patient to be seen by neurology to rule out any underlying issues present.Patient will not be continuing with tms therapy.

• Brand Name: NEUROSTAR ADVANCED THERAPY SYSTEM
• 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: 20599257
• Report Number: 3004824012-2024-00023
• Device Sequence Number: 8943609
• Product Code: OBP
• UDI-Device Identifier: 00850005944058
• UDI-Public: 00850005944058
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Health Professional
• Initial Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 11/04/2024

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: VERSION 3.6
• Device Catalogue Number: 81-03315-000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 11/04/2024
• 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: ABILIFY; CARDIZEM; LOSARTAN; SPRAVATO; TRILEPTAL
• Outcome Attributed to Adverse Event: Other
• Patient Age: 28 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Race: White