NEUROSTAR

Description of Event or Problem

NEURONETICS RECEIVED INFORMATION FROM THE SOCIAL MEDIA MONITOR REGARDING A PATIENT ALLEGING THE FOLLOWING ADVERSE EVENTS: MIGRAINE HEADACHES, FLASH PAINS IN HEAD, MEMORY LOSS AND SLOWED SPEECH.

Additional Manufacturer Narrative

THE PERSON ALLEGING SERIOUS ADVERSE EVENTS ON SOCIAL MEDIA DID NOT RESPOND TO OUTREACH BY THE SOCIAL MEDIA MONITOR AND THEREFORE NO ADDITIONAL INFORMATION COULD BE COLLECTED TO CONDUCT A THOROUGH INVESTIGATION. NEURONETICS WAS UNABLE TO CONFIRM THAT THE PERSON WAS TREATED WITH A NEUROSTAR DEVICE BUT IS SUBMITTING THIS MDR OUT OF AN ABUNDANCE OF CAUTION.