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

Model Number	NEUROSTAR ADVANCED THERAPY V3.7.1
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Anxiety (2328)
Date of Event	07/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Tms treater reported that one of their patients was experiencing increased anxiety after receiving 10 treatments.Patient received 9 treatments of standard tms treatment and 1 treatment of theta burst, after which patient reported increased anxiety.Patient is currently on her second course of tms.Patient has been experiencing "a lot of life issues" recently and is "really overwhelmed".According to the provider, the patient is not an any medications but provider prescribed patient a benzodiazepine in response to her increased anxiety, although the patient admitted to not taking it.Patient has continued with standard tms treatment and was on her 15th session out of 36.Based on the provided information, it can not be ruled out whether her increased anxiety was due to the theta burst session, her personal issues, or a combination of these factors.
Event or Problem Description
Neuronetics received a call from a tms provider which reported that one of their patients experiencing increased anxiety with treatment.

• 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: 17452988
• Report Number: 3004824012-2023-00016
• Device Sequence Number: 7383532
• Product Code: OBP
• UDI-Device Identifier: 00850005944522
• UDI-Public: 00850005944522
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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): 08/03/2023

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
• Operator of Device: Health Professional
• Device Model Number: NEUROSTAR ADVANCED THERAPY V3.7.1
• Device Catalogue Number: 81-02315-000
• 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: 07/06/2023
• Initial Report FDA Received Date: 08/03/2023
• 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: BENZODIAZEPINE
• Outcome Attributed to Adverse Event: Other
• Patient Age: 35 YR
• Patient Sex: Female
• Patient Weight: 74 KG