NEUROSTAR ADVANCED THERAPY SYSTEM
Received Feb 24, 2025 · Event occurred Jan 27, 2025
Report 3004824012-2025-00003 · MDR key 21446161
Device
Generic name
Transcranial Magnetic Stimulation
Manufacturer
Neuronetics, Inc.Model number
NEUROSTAR 3.XCatalog number
81-02315-00R
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
55 YR · Male
- Balance Problems
- Balance Problems
Narrative
Additional Manufacturer Narrative
THE PATIENT COMPLETED HIS COURSE OF TMS TREATMENT AND SAW IMPROVEMENT IN HIS DEPRESSION SCORES. THE PATIENT HAS PRE-EXISTING HAND TREMORS AND IT IS UNKNOWN IF THE BALANCE ISSUES ARE DUE TO AN UNDERLYING NEUROLOGICAL DISORDER. THE PATIENT HAS A NEUROLOGIST APPOINTMENT BOOKED IN THE NEAR FUTURE. THE INFORMATION PROVIDED IS INCONCLUSIVE ON HOW TMS MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S SYMPTOMS. DUE TO THE FOUR FALLS THE PATIENT ALLEGES, THE COMPANY IS REPORTING OUT OF AN ABUNDANCE OF CAUTION.
Description of Event or Problem
PATIENT REPORTED HAVING BALANCE ISSUES AND FALLING 4 TIMES OVER THE PAST 30 DAYS DURING TMS TREATMENT. THE PATIENT WAS NOT SERIOUSLY INJURED DURING THE FALLS, BUT BALANCE ISSUES CONTINUED THROUGHOUT AND AFTER TMS TREATMENT. PATIENT IS SCHEDULED TO SEE A NEUROLOGIST IN THE NEAR FUTURE.