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

Model Number	NEUROSTAR ADVANCED THERAPY V3.7
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	10/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Provider contacted neuronetics to report that one of their patients experienced a non-epileptic seizure around 8:30-9:00 pm.The patient had received her 18th tms treatment session earlier that same day around 3:00 pm.The patient reportedly was sleeping and got up to go to the bathroom which is when the event occurred.The patient's husband called 911 and the patient was taken to the er and was subsequently admitted to the hospital for 5 days.Patient had an eeg and mri which were found to be normal.The patient also met with a neurologist while in the hospital though patient reported that they did not "find out a reason" for the event.The patient was on lamictal previously for her mdd but in response to the event, her dose was increased.The patient is on several medications that could potentially lower the seizure threshold and has had a similar episode of non-epileptic seizure in the past.Per the provider, the patient has not been taking her medications as prescribed.These factors could have contributed to the event.
Event or Problem Description
Provider contacted neuronetics to report that one of their patients experienced a seizure in the middle of the night and was subsequently hospitalized.Patient had received their 18th tms treatment session earlier the same day the event occurred.

• 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: 18187409
• Report Number: 3004824012-2023-00026
• Device Sequence Number: 6646954
• Product Code: OBP
• UDI-Device Identifier: 00850005944522
• UDI-Public: 00850005944522
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K230029
• 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): 11/27/2023

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 ADVANCED THERAPY V3.7
• Device Catalogue Number: 81-04335-000
• 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: Not provided
• Initial Report FDA Received Date: 11/21/2023
• 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: BUSPAR 15 MG THREE TIMES A DAY; LAMICTAL 200 MG DAILY; PRISTIQ 100 MG DAILY; REMERON 15 MG AT BEDTIME; TRAZODONE 50 MG AT BEDTIME
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Race: White