InjuryOBP
NEUROSTAR ADVANCED THERAPY
Received Apr 19, 2023 · Event occurred Jan 30, 2023
Report 3004824012-2023-00009 · MDR key 16771069
Device
Generic name
Transcranial Magnetic Stimulator
Manufacturer
Neuronetics, Inc.Model number
NEUROSTAR ADVANCED THERAPY 3.0Catalog number
81-02315-000
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
31 YR · Female
- Head Injury
- Hearing Impairment
- Nausea
- Vertigo
- Sleep Dysfunction
- Skin Inflammation/ Irritation
- Head Injury
- Hearing Impairment
- Nausea
- Vertigo
- Sleep Dysfunction
- Skin Inflammation/ Irritation
Narrative
Additional Manufacturer Narrative
THE TMS PROVIDER COULD NOT BE REACHED TO PROVIDE ADDITIONAL INFORMATION AND THEREFORE A FULL INVESTIGATION COUD NOT BE COMPLETED.
Description of Event or Problem
NEURONETICS RECEIVED A PATIENT REPORTED MEDWATCH (MW5115632) FROM FDA ALLEGING THAT THE PATIENT HAD ADVERSE REACTIONS FROM 20-30 TMS THERAPY TREATMENTS INCLUDING HEADACHES, SLEEP INTERUPTIONS, SCALP IRRITATION, VERTIGO, NAUSEA AND EARDRUM TWITCHING THAT AFFECTS HEARING.