NERIVO

Description of Event or Problem

I WAS USING THE NERIVO DEVICE TO TREAT A MIGRAINE. I'VE USED THESE DEVICES IN THE PAST WITH NO ISSUES THIS IS THE 16TH TIME THAT I USED A NERIVO DEVICE. THIS TIME, WHILE USING IT, I RECEIVED SHOCKS UP AND DOWN MY LEFT ARM. IT WAS SET TO AN INTENSITY OF 49% AT THAT TIME. I PREVIOUSLY HAD TREATMENTS USING AN INTENSITIES UP TO 60%. I EVENTUALLY REMOVED THE DEVICE AND STOPPED TREATMENT EARLY. I WAS SITTING DOWN ON A COUCH WHILE USING IT. THE TEMPERATURE IN THE HOUSE WAS APPROXIMATELY 68 DEGREES, I WAS WEARING A SHORT-SLEEVE SHIRT AND I WAS NOT SWEATING. THE DEVICE WAS ON MY LEFT UPPER ARM. FDA SAFETY REPORT ID # (B)(4).