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

Model Number	NS 3.6
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Headache (1880); Dizziness (2194)
Date of Event	01/13/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient sees a neurologist every 12 weeks for regular care and treatment including botox for the pain of the vestibular migraines, however she always deals with vertigo and dizziness to some extent.She also suffers from benign positional vertigo.Vestibular migraines started in 2007 and were diagnosed in 2014 with some episodes lasting days to several months.The initial symptoms have lessened in intensity since her last treatment.She only had three treatments total.Her triggers for vestibular migraines are stress, any change in her routine, lack of sleep and some foods.She stated that her stress is very high due to some upcoming surgeries with both of her young children.After the surgery of her children, she may resume her tms treatments.
Event or Problem Description
A tms provider contacted neuronetics regarding a patient who reported the following: "my brain has gone a bit wonky with the treatments.About three hours after treatment, it's like a seismic wave goes off in my brain, and i'm hit with a wave of dizziness.The first two times it resolved completely.I did take relpax.The third time it didn't resolve.My brain hasn't gone back to regular vestibular wise since my treatment on friday.I had a smaller wave of offness/dizziness hit me during the treatment and after the seismic wave like feeling in my brain, it escalated that night and stayed through the weekend.".

• Brand Name: NEUROSTAR ADVANCED THERAPY
• Common Device Name: TRANSCRANIAL MAGNETIC STIMULATOR
• Manufacturer (Section D): NEURONETICS, INC.; 3222 phoenixville pike; malvern PA 19355
• Manufacturer Contact: robin fatzinger ; 3222 phoenixville pike; malvern, PA 19355 ; 6106404202
• MDR Report Key: 16326454
• Report Number: 3004824012-2023-00004
• Device Sequence Number: 18288282
• Product Code: OBP
• UDI-Device Identifier: 00850005944058
• UDI-Public: 00850005944058
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 02/08/2023

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: NS 3.6
• Device Catalogue Number: 81-03315-000
• 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: 01/17/2023
• Initial Report FDA Received Date: 02/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: BOTOX; RELPAX FOR VESTIBULAR MIGRAINES
• Outcome Attributed to Adverse Event: Other
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic