NEUROSTAR ADVANCED THERAPY SYSTEM
Received Feb 24, 2025 · Event occurred Feb 7, 2025
Report 3004824012-2025-00004 · MDR key 21446525
Device
Generic name
Transcranial Magnetic Stimulation
Manufacturer
Neuronetics, Inc.Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Memory Loss/Impairment
- Tinnitus
- Brain Injury
- Anxiety
- Cognitive Changes
- Unspecified Mental, Emotional or Behavioural Problem
- Memory Loss/Impairment
- Tinnitus
- Brain Injury
- Anxiety
- Cognitive Changes
- Unspecified Mental, Emotional or Behavioural Problem
Narrative
Additional Manufacturer Narrative
THE PATIENT DID NOT RESPOND TO THE SOCIAL MEDIA MONITOR'S REQUEST TO CONTACT NEURONETICS AND THEREFORE THE COMPANY WAS UNABLE TO VERIFY THE PATIENT HAD BEEN TREATED WITH A NEUROSTAR DEVICE. FURTHERMORE, ADDITIONAL INFORMATION COULD NOT BE COLLECTED TO CONDUCT A THOROUGH INVESTIGATION. REPORTING OUT OF AN ABUNDANCE OF CAUTION SINCE THE CAUSUAL RELATIONSHIP BETWEEN THE PATIENT'S SYMPTOMS AND TMS COULD NOT BE RULED OUT BASED ON THE INFORMATION PROVIDED.
Description of Event or Problem
NEURONETICS WAS MADE AWARE OF A POST ON FACEBOOK, BY THE COMPANY'S SOCIAL MEDIA MONITOR, ALLEGING "TRAUMATIC BRAIN INJURY (TBI), COGNITIVE IMPAIRMENT, EXTREME SOMATIC ANXIETY, DISASSOCIATION DISORDER, TINNITUS, MEMORY LOSS, AND MORE."