NEUROSTAR ADVANCED THERAPY
Received Aug 3, 2023 · Event occurred Jul 6, 2023
Report 3004824012-2023-00017 · MDR key 17452971
Device
Generic name
Transcranial Magnetic Stimulator
Manufacturer
Neuronetics, Inc.Model number
NEUROSTAR ADVANCED THERAPY V1.0Catalog number
81-60000-000
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
68 YR · Female
- Vertigo
- Dizziness
- Vertigo
- Dizziness
Narrative
Additional Manufacturer Narrative
PATIENT REPORTED THAT SHE WOKE UP THE NEXT DAY AFTER RECEIVING TMS AND WAS "FEELING DIZZY". PATIENT WENT TO HER PRIMARY CARE PHYSICIAN AND REPORTEDLY SAID THAT SHE MIGHT HAVE VERTIGO. PATIENT HAD EXPERIENCED A SIMILAR EPISODE OF VERTIGO PRIOR TO BEGINNING TMS. AFTER TAKING A FEW DAYS OFF FROM TMS, THE PATIENT RESTARTED TREATMENT THEN STOPPED AFTER A FEW DAYS AS SHE WAS "NERVOUS" TO CONTINUE AND WILL BE SEEING A NEUROLOGIST FOR EVALUATION. PATIENT'S TMS PROVIDER IS UNSURE WHAT TO ATTRIBUTE THE COMPLAINT TO THOUGH HAS REPORTED THAT PATIENT IS CURRENTLY STABLE AND THAT VERTIGO IS NOT DEBILITATING.
Description of Event or Problem
NEURONETICS RECEIVED A CALL FROM A TMS PROVIDER REPORTING THAT ONE OF THEIR PATIENT'S EXPERIENCED VERTIGO AND DIZZINESS THE NEXT DAY AFTER RECEIVING THEIR 7TH TREATMENT.