inforMED
InjuryOBP

NEUROSTAR ADVANCED THERAPY

Received Mar 3, 2026 · Event occurred Feb 6, 2026

Report 3004824012-2026-00008 · MDR key 24503866

Device

Generic name

Tms

Manufacturer

Neuronetics, Inc.

Model number

V.3.8

Catalog number

81-05315-000

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

20 YR · Female

  • Convulsion/Seizure

Narrative

Description of Event or Problem

PATIENT EXPERIENCED A SEIZURE DURING HER 30TH DAILY TREATMENT AFTER RECEIVING 1,907 PULSES. PATIENT WAS TREATED BY EMS AND TAKEN TO THE ER IN STABLE CONDITION.

Additional Manufacturer Narrative

PROVIDER ATTRIBUTES TO MEDICATION NON-COMPLIANCE ISSUE: PATIENT REPORTEDLY RAN OUT OF VENLAFAXINE, DID NOT INFORM PRESCRIBING PROVIDER OR TMS STAFF AT FIRST, THEN MAY HAVE RESUMED MEDICATION WITHOUT DISCUSSING WITH PRESCRIBING PROVIDER. PATIENT IS NOT CONTINUING TMS AS THEIR DEPRESSION SCORES ARE HOVERING AROUND REMISSION. PATIENT WILL BE SEEN BY A NEUROLOGIST.