InjuryOBP
NEUROSTAR ADVANCED THERAPY
Received Nov 20, 2024 · Event occurred Oct 15, 2024
Report 3004824012-2024-00028 · MDR key 20737983
Device
Generic name
Transcranial Magnetic Stimulation
Manufacturer
Neuronetics, Inc.Model number
NEUROSTAR 2.0Catalog number
81-01315-000
Lot number
NA
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
41 YR · Male
- Vertigo
- Vertigo
Narrative
Description of Event or Problem
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.