inforMED
InjuryOBP

NEUROSTAR

Received Sep 3, 2025 · Event occurred Aug 1, 2025

Report 3004824012-2025-00047 · MDR key 22954044

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Product code (OBP)
Manufacturer (Neuronetics Inc.)
Model (NEUROSTAR TMS THERAPY SYSTEM)

Device

Generic name

Tms

Manufacturer

Neuronetics, Inc.

Product problems

  • Patient-Device Incompatibility
  • Patient-Device Incompatibility

Patient

20 YR · Female

  • Headache
  • Numbness
  • Eye Pain
  • Headache
  • Numbness
  • Eye Pain

Narrative

Description of Event or Problem

NEURONETICS RECEIVED A REPORT FROM ITS JAPANESE DISTRIBUTOR THAT A PATIENT "COMPLAINED" OF MIGRAINE, DEEP EYE SOCKET PAIN AND RIGHT-SIDE BODY NUMBNESS. WHILE THE EYE PAIN AND NUMBNESS HAVE RESOLVED THE MIGRAINE PERSISTS AND PATIENT IS BEING TREATED BY A NEUROLOGIST.