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

Model Number	NEUROSTAR 3.7
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hallucination (4428)
Date of Event	10/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Provider contacted neuronetics to inform the company that a patient was experiencing auditory hallucinations after 16 tms treatments.
Additional Manufacturer Narrative
Patient reported that the auditory hallucinations were mainly annoying, not impacting his daily life, and were not telling him to harm himself.He has stopped his tms treatment and has been prescribed vraylar to help with the hallucinations and depression.Tms is not known to cause auditory hallucinations.Based on the information provided it is not known if tms may have caused or contributed to the patient's condition.

• 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 ; 6106404202
• MDR Report Key: 20738027
• Report Number: 3004824012-2024-00027
• Device Sequence Number: 8297871
• Product Code: OBP
• UDI-Device Identifier: 00850005944522
• UDI-Public: 00850005944522
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Physician
• 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: NEUROSTAR 3.7
• Device Catalogue Number: 81-04315-000
• 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: 10/30/2024
• 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: CYMBALTA; DULOXETINE 90MG; TRAZODONE; VRAYLAR 1.5MG RX FOR AUDITORY HALLUCINATIONS; WELLBUTRIN XL 300MG
• Outcome Attributed to Adverse Event: Other
• Patient Age: 49 YR
• Patient Sex: Male