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

Model Number	NEUROSTAR 2.0
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Vertigo (2134)
Date of Event	10/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Practice notified a neuronetics representative that a patient was experiencing vertigo starting after their first treatment.Patient's vertigo would increase as the %smt was increased so they were unable to get him to his full "prescription" strength.The vertigo affected the patient's daily routine, work and mood.Vertigo completely resolved after discontinuing tms treatment, after the 12th treatment, and the patient's mood is completely fine.

• 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: 20737983
• Report Number: 3004824012-2024-00028
• Device Sequence Number: 12833973
• Product Code: OBP
• UDI-Device Identifier: 00869378000100
• UDI-Public: 00869378000100
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: DEN070003
• 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): 11/19/2024

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 2.0
• Device Catalogue Number: 81-01315-000
• 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: 11/06/2024
• 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: ZOLOFT 25MG.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 41 YR
• Patient Sex: Male