inforMED
InjuryOBP

NEUROSTAR

Received May 8, 2025

Report 3004824012-2025-00011 · MDR key 21984314

Device

Generic name

Tms

Manufacturer

Neuronetics, Inc.

Catalog number

81-03315-000

Product problems

  • Patient-Device Incompatibility
  • Patient-Device Incompatibility

Patient

NA · Unknown

  • Tics/Tremor
  • Tics/Tremor

Narrative

Additional Manufacturer Narrative

NEURONETICS WAS UNABLE TO OBTAIN PATIENT AND TREATMENT INFORMATION, FROM THE REPORTING PHYSICIAN, IN ORDER TO CONDUCT A THOROUGH INVESTIGATION AND DETERMINE POTENTIAL CAUSATION.

Description of Event or Problem

A PRACTICE NOTIFIED NEURONETICS THAT A PATIENT STARTED HAVING TREMORS AFTER RECEIVING A FULL COURSE OF TMS TREATMENT.