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

Model Number	NEUROSTAR ADVANCED THERAPY 3.0
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vertigo (2134)
Date of Event	05/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient had a history of concussion ((b)(6) 2022) but had no history of vertigo until starting tms treatment.During hospitalization, patient was told that the vertigo was due to an ear condition.The patient's medication regimen is unknown other than she started taking aspirin and meclizine after the hospitalization.The patient has continued to receive tms treatment and her vertigo symptoms have persisted but are subsiding.
Event or Problem Description
Neuronetics received a call from a tms provider indicating that a patient was hospitalized for dizziness, weakness and headaches during first week of tms treatment.Patient diagnosed with benign paroxysmal postural vertigo (bppv).

• 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: robin fatzinger ; 3222 phoenixville pike; malvern, PA 19355 ; 6109814027
• MDR Report Key: 17137353
• Report Number: 3004824012-2023-00013
• Device Sequence Number: 14945464
• Product Code: OBP
• UDI-Device Identifier: 00850005944430
• UDI-Public: 00850005944430
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2023

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 3.0
• Device Catalogue Number: 81-02315-00R
• 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: 05/16/2023
• Initial Report FDA Received Date: 06/15/2023
• 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: ASPRIN; MECLIZINE
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 88 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White