InjuryOBP
NEUROSTAR
Received May 16, 2025 · Event occurred Apr 18, 2025
Report 3004824012-2025-00013 · MDR key 22036150
Device
Generic name
Tms
Manufacturer
Neuronetics, Inc.Model number
NEUROSTAR ADVANCED THERAPY 3.8Catalog number
81-05315-000
Product problems
- Patient-Device Incompatibility
- Patient-Device Incompatibility
Patient
37 YR · Female
- Emotional Changes
- Emotional Changes
Narrative
Additional Manufacturer Narrative
THE TREATING PHYSICIAN NOTED THAT THERE WAS A MEDICATION CHANGE DURING THE PATIENT'S TREATMENT WHICH MAY HAVE CONTRIBUTED TO THE INCREASED ANXIETY.
Description of Event or Problem
A PRACTICE NOTIFIED NEURONETICS THAT A PATIENT EXPERIENCED WORSENING ANXIETY AND RESURFACING OF PTSD IN HER DREAMS AFTER STARTING TMS TREATMENT. SHE STOPPED AFTER 7 TREATMENTS.