InjuryOBP
NEUROSTAR
Received Aug 26, 2025 · Event occurred Jul 23, 2025
Report 3004824012-2025-00044 · MDR key 22899690
Device
Generic name
Tms
Manufacturer
Neuronetics, Inc.Model number
NEUROSTAR TMS THERAPY SYSTEM 3.0Catalog number
81-02315-000
Product problems
- Patient-Device Incompatibility
- Patient-Device Incompatibility
Patient
20 YR · Male
- Depression
- Suicidal Ideation
- Depression
- Suicidal Ideation
Narrative
Additional Manufacturer Narrative
BASED ON THE INFORMATION PROVIDED IT CAN NOT BE DETERMINED IF NEUROSTAR TREATMENT CAUSED OR CONTRIBUTED TO THE PATIENT'S SYMPTOMS. THE TREATING PHYSICIAN STATED THAT THEY DID NOT THINK TMS TREATMENT WAS RESPONSIBLE FOR HIS SUICIDAL IDEATION.
Description of Event or Problem
NEURONETICS RECIEVED INFORMATION FROM A PRACTICE THAT A PATIENT WAS EXPERIENCING WORSENING DEPRESSION, INCREASED IRRITABILITY, AND SUICIDAL IDEATION AFTER TREATMENT SESSION NUMBER 8. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2025 FOR THE SUICIDAL IDEATION.