InjuryOBP
NEUROSTAR ADVANCED THERAPY
Received Nov 20, 2024 · Event occurred Jan 5, 2024
Report 3004824012-2024-00030 · MDR key 20739668
Device
Generic name
Transcranial Magnetic Stimulation
Manufacturer
Neuronetics, Inc.Model number
UNKNOWNCatalog number
UNKNOWN
Lot number
NA
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
28 YR · Female
- Memory Loss/Impairment
- Irritability
- Speech Disorder
- Memory Loss/Impairment
- Irritability
- Speech Disorder
Narrative
Additional Manufacturer Narrative
THE MEDWATCH WAS RECEIVED WITH A PATIENT NAME BUT NO CONTACT INFORMATION. THEREFORE, IT CAN NOT BE CONFIRMED THAT THE PATIENT WAS TREATED ON A NEUROSTAR DEVICE NOR COULD A THOROUGH INVESTIGATION BE PERFORMED.
Description of Event or Problem
NEURONETICS RECEIVED A MEDWATCH (MW5161005) FROM FDA ON NOVEMBER 14, 2024, REGARDING A PATIENT THAT ALLEGES SHE EXPERIENCED SHORT TERM MEMORY ISSUES, BRAIN FOG, IRRITABILITY, SOUND SENSITIVITY, AND ANOMIC APHASIA AFTER RECEIVING 57 TMS TREATMENTS.