InjuryOBP

NEUROSTAR

Received Jul 22, 2025 · Event occurred Jun 27, 2025

Report 3004824012-2025-00042 · MDR key 22571349

Device

Generic name

Tms

Manufacturer

Neuronetics, Inc.

Model number

NEUROSTAR 3.0

Catalog number

81-02315-000

Product problems

Patient-Device Incompatibility
Patient-Device Incompatibility

Patient

35 YR · Female

Emotional Changes
Headache
Suicidal Ideation
Emotional Changes
Headache
Suicidal Ideation

Narrative

Description of Event or Problem

PATIENT REPORTED TO NEURONETICS THAT SHE HAD EXPERIENCED DEBILITATING MIGRAINES, WORSENING DEPRESSION AND SUICIDAL IDEATION AFTER RECEIVING TMS TREATMENTS. THE PATIENT DISCONTINUED TREATMENT AFTER HER 10TH SESSION.

Additional Manufacturer Narrative

BASED ON THE INFORMATION PROVIDED, NO CONCLUSION CAN BE MADE ON HOW TMS MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S CONDITIONS.