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

Model Number	VERSION 3.0
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Convulsion/Seizure (4406)
Date of Event	11/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Seizure is a rare but serious known risk of tms.However a cause for the atrial fibrilation (af) is unknown.Af is not an established adverse event of tms.
Event or Problem Description
A practice called neuronetics to report that a patient had a tonic clonic seizure during her first treatment session.The patient was taken to the er and experienced atrial fibrillation while there.The patient was unaware of any cardiac issues prior to this event.The patient will not continue with tms treatment.

• Brand Name: NEUROSTAR ADVANCED THERAPY
• 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: 20738302
• Report Number: 3004824012-2024-00029
• Device Sequence Number: 18304999
• Product Code: OBP
• UDI-Device Identifier: 00869378000117
• UDI-Public: 00869378000117
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K161519
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 11/19/2024

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 3.0
• Device Catalogue Number: 81-02315-000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 11/20/2024
• 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: LEXAPRO
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White