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

Model Number	NEUROSTAR ADVANCED THERAPY SYSTEM V3.0
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Codes	Nausea (1970); Syncope/Fainting (4411)
Date of Event	05/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Neuronetics was contacted by a provider reporting that one of their patients became nauseous during his first treatment session and treatment was paused.The patient began burping before passing out.Patient reportedly experienced a brief period of shaking before quickly "falling asleep".The provider assessed the patient and concluded that patient most likely experienced a vasovagal response but sent patient to the emergency room for further evaluation.Patient was noted to have a history of syncopal episodes with the most recent occurring in (b)(6) 2024.Upon investigation, the treatment location that was used suggests that the coil placement may have been too close to the patient's motor strip based on the patient's stature and size which could have resulted in the reported adverse event.Patient will be following up with cardiology for clearance to return to treatment as this is the patient's second syncopal episode within a 3-month period.
Event or Problem Description
Neuronetics was contacted by a provider that reported one of their patients became nauseous and proceeded to pass out during his first treatment session.The treater noted that while the patient was passed out, he experienced a period of "brief shaking" before falling "into a deep sleep" and began to snore.Patient was sent to the er as a precaution.

• 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
• MDR Report Key: 19511418
• Report Number: 3004824012-2024-00016
• Device Sequence Number: 20707478
• Product Code: OBP
• UDI-Device Identifier: 00869378000117
• UDI-Public: 00869378000117
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 06/11/2024

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 SYSTEM V3.0
• Device Catalogue Number: 81-01335-000
• 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: 05/30/2024
• Initial Report FDA Received Date: 06/11/2024
• 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: AUSTEDO XR 36 MG; BUSPAR 30 MG BID; KLONOPIN 1 MG BID; MELOXICAM 15 MG BID; PRIMIDONE 50 MG QD; TRAZODONE 25-50 MG QHS; ZOLOFT 100 MG QD
• Outcome Attributed to Adverse Event: Other
• Patient Age: 35 YR
• Patient Sex: Male
• Patient Weight: 144 KG
• Patient Race: White