NEUROSTAR

Description of Event or Problem

NEURONETICS RECEIVED A NEGATIVE COMMENT FROM THE COMPANY'S SOCIAL MEDIA MONITOR ALLEGING THAT TMS CAUSED WORSENING TINNITUS.

Additional Manufacturer Narrative

THE PATIENT DID RESPOND TO NEURONETICS OUTREACH AND PROVIDED ADDITIONAL INFORMATION BY TELEPHONE. THE PATIENT HAS A HISTORY OF TINNITUS AND WAS NOT WEARING THE PRESCRIBED EARPLUGS DURING THE FIRST WEEK OF TREATMENT. AFTER HIS TINNITUS STARTED TO WORSEN HE USED EARPLUGS FOR THE REST OF HIS TREATMENTS. HE REPORTS BEING TREATED ON THE RIGHT SIDE FOR THREE TREATMENTS (WHICH IS OFF LABEL PROTOCOL) AND THAT ALSO SEEMED TO INCREASE THE TINNITUS.