BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAMMA CORE DEVICE

    MDR report key: 8111082 · Received November 27, 2018

    Report

    Report Number
    MW5081676
    Event Type
    Injury
    Date Received
    November 27, 2018
    Date of Event
    November 19, 2018
    Report Date
    November 26, 2018
    Manufacturer
    UNK
    Product Code
    QAK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I TOOK MY SON ((B)(6)) TO THE NEUROLOGIST THIS PAST MONDAY FOR A CHECK UP AND MED REVIEW. WHILE THERE, THE DR DECIDED TO TRY THE GAMMA CORE DEVICE ON HIM STATING IT WOULD EITHER HELP OR NOT. IF IT HELPED HE WOULD GET US THE PAPERWORK NEEDED TO GET ONE. MY SON WAS SEATED ON THE EXAM TABLE AND THE NURSE PUT 30 SECS ON THE DEVICE AND PUT SOME GEL ON THE DEVICE AND PUT IT TO MY SON'S NECK / JAWLINE. HE STATED THAT IT FELT REALLY WEIRD AND ASKED, COULD THEY DO IT WITH HIM LAYING DOWN. THE NURSE WENT AND ASKED THE DR AND CAME BACK INTO THE ROOM AND SAID YES HE COULD. THE DR WAS NOT PRESENT DURING THIS NEW PROCEDURE, BY THE WAY. MY SON HAD JUST LAID DOWN, STATED HE FELT WEIRD THEN HIS WHOLE BODY SEIZED UP, EYES ROLLED BACK IN HIS HEAD AND WAS UNRESPONSIVE FOR APPROX 1 TO 2 MINS. HE FINALLY RESPONDED TO ME FOR MAY BE 1 MIN, THEN STARTED TO SEIZE UP AGAIN WITH EYES ROLLING BACK AND UNRESPONSIVE FOR ANOTHER MIN OR TWO. HE HAD NEVER HAD A SEIZURE BEFORE, THE SQUAD WAS CALLED AND WE WERE SENT TO THE ER. THEY DREW BLOOD, DID CT SCAN AND GAVE HIM FLUID BUT CAME BACK WITH NO ANSWERS AS TO WHAT HAPPENED. HIS NEUROLOGIST SAID ANXIETY ATTACK BUT MY SON SAYS ABSOLUTELY NOT. HE HAS HAD PANIC ATTACKS BEFORE AND THIS WASN'T EVEN CLOSE. HE SAID HE WAS COMING IN AND OUT OF CONSCIOUSNESS, AND FELT LIKE HE WAS DYING. SO I AM WRITING TO YOU IN HOPES THAT YOU MIGHT HAVE ANSWERS OR HELPFUL INFO AS TO WHAT HAPPENED. EVERYTHING I READ ABOUT THIS DEVICE IS THAT IT'S COMPLETELY SAFE AND NON EVASIVE. GOING TO A NEUROLOGIST AS SOON AS POSSIBLE FOR AN EEG BUT NEED ANSWERS AS TO WHAT HAPPENED. NO ONE SEEMS TO KNOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948367 GAMMA CORE DEVICE NON - INVASIVE VAGUS NERVE STIMULATOR - HEADACHE QAK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other