NEUROSTAR
Received Aug 28, 2025 · Event occurred Jun 9, 2025
Report 3004824012-2025-00045 · MDR key 22919321
Device
Generic name
Tms
Manufacturer
Neuronetics, Inc.Model number
NEUROSTAR TMS THERAPY SYSTEM 3.7Catalog number
81-04315-000
Product problems
- Patient-Device Incompatibility
- Patient-Device Incompatibility
Patient
29 YR · Male
- Depression
- Sleep Dysfunction
- Depression
- Sleep Dysfunction
Narrative
Additional Manufacturer Narrative
THE PATIENT DID RESPOND TO QUESTIONS FROM NEURONETICS AND REPORTED THAT THE INSOMNIA HAS IMPROVED SOMEWHAT SINCE MAKING THE MEDWATCH REPORT. HE HAS DIFFICULTY STAYING ASLEEP EVEN WITH THE MEDICATION AND GETS ABOUT 4-6 HOURS OF SLEEP/NIGHT. HE DID INDICATE THAT HE HAS ALWAYS HAD SLEEP DIFFICULTY WHICH MAY BE RELATED TO HIS ADHD AND/OR CHRONIC INTERNET ADDICTION.
Description of Event or Problem
NEURONETICS RECEIVED A MEDWATCH FROM FDA (MW5173067) ALLEGING THAT NEUROSTAR TMS TREATMENT RESULTED IN WORSENING DEPRESSION AND PERSISTENT INSOMNIA AFTER 1.5 WEEKS OF TREATMENT.