NEUROSTAR ADVANCED THERAPY
Received Nov 20, 2024 · Event occurred Oct 24, 2024
Report 3004824012-2024-00027 · MDR key 20738027
Device
Generic name
Transcranial Magnetic Stimulation
Manufacturer
Neuronetics, Inc.Model number
NEUROSTAR 3.7Catalog number
81-04315-000
Lot number
NA
Product problems
- Patient Device Interaction Problem
- Patient Device Interaction Problem
Patient
49 YR · Male
- Hallucination
- Hallucination
Narrative
Description of Event or Problem
PROVIDER CONTACTED NEURONETICS TO INFORM THE COMPANY THAT A PATIENT WAS EXPERIENCING AUDITORY HALLUCINATIONS AFTER 16 TMS TREATMENTS.
Additional Manufacturer Narrative
PATIENT REPORTED THAT THE AUDITORY HALLUCINATIONS WERE MAINLY ANNOYING, NOT IMPACTING HIS DAILY LIFE, AND WERE NOT TELLING HIM TO HARM HIMSELF. HE HAS STOPPED HIS TMS TREATMENT AND HAS BEEN PRESCRIBED VRAYLAR TO HELP WITH THE HALLUCINATIONS AND DEPRESSION. TMS IS NOT KNOWN TO CAUSE AUDITORY HALLUCINATIONS. BASED ON THE INFORMATION PROVIDED IT IS NOT KNOWN IF TMS MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S CONDITION.