NEUROSTAR ADVANCED THERAPY
Received Jun 15, 2023 · Event occurred May 14, 2023
Report 3004824012-2023-00013 · MDR key 17137353
Device
Generic name
Transcranial Magnetic Stimulator
Manufacturer
Neuronetics, Inc.Model number
NEUROSTAR ADVANCED THERAPY 3.0Catalog number
81-02315-00R
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
51 YR · Female
- Vertigo
- Vertigo
Narrative
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.
Description of Event or Problem
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).