inforMED
InjuryOBP

NEUROSTAR

Received May 25, 2025 · Event occurred Apr 3, 2025

Report 3004824012-2025-00025 · MDR key 22082671

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

54 YR · Female

  • Balance Problems
  • Speech Disorder
  • Balance Problems
  • Speech Disorder

Narrative

Description of Event or Problem

PATIENT ALLEGES THAT TMS TREATMENT HAS AFFECTED HER WALKING AND CAUSED HER TO STUTTER WHICH NEGATIVELY IMPACTS HER ABILITY TO WORK.

Additional Manufacturer Narrative

THE PRACTICE NOTES INDICATED THAT THE PATIENT USED A CANE PRIOR TO THE START OF TMS AND DID NOT NOTICE A PERSISTENT STUTTER. THESE ADVERSE EVENTS ARE NOT KNOWN TO BE ASSOCIATED WITH TMS TREATMENT AND A CONCLUSION ABOUT THE RELATEDNESS CAN NOT BE MADE BASED ON THE INFORMATION PROVIDED.