BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STMS MINI

    MDR report key: 8879917 · Received August 9, 2019

    Report

    Report Number
    3008487930-2019-00001
    Event Type
    Injury
    Date Received
    August 9, 2019
    Date of Event
    July 17, 2019
    Report Date
    July 17, 2019
    Manufacturer
    ENEURA, INC.
    Product Code
    OKP
    PMA / PMN Number
    K161663
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT BEGAN TREATMENT OF HER CHRONIC HEMIPLEGIC MIGRAINES WITH THE STMS MINI ON (B)(6) 2019 AND DELIVERED TWO "CLICKS" AS DIRECTED IN THE WRITTEN INSTRUCTIONS AND AS PRESCRIBED BY HER DOCTOR. PRIOR TO USING THE STMS MINI, THE PATIENT WAS FEELING WELL WITH NO SYMPTOMS OF MIGRAINE. AFTER THE FIRST CLICK, THE PATIENT HAD A SENSATION OF SOMETHING ODD HAPPENING IN HER BRAIN. IMMEDIATELY AFTER THE SECOND CLICK, SHE BEGAN TO HAVE THE USUAL SYMPTOMS THAT OCCUR WITH HER MORE SEVERE MIGRAINES: SIGNIFICANT FACIAL SAGGING, EXTREME DROOPING OF HER RIGHT EYELID, TINGLING IN HER RIGHT ARMA ND HAND, ANXIETY, CONFUSION. ADDITIONALLY SHE REPORTED A SENSATION THAT SOMETHING WAS "WRONG" IN HER BRAIN. WITHIN 10 MINUTES, SHE WAS HAVING A FULL BLOWN MIGRAINE ALONG WITH AN UNUSUAL PRESSURE SENSATION AROUND THE TOP OF HER HEAD. IT WAS UNUSUAL FOR HER TO FEEL PRESSURE AROUND HER WHOLE HEAD INSTEAD OF ONLY ON THE RIGHT SIDE. HER COGNITIVE FUNCTION WORSENED, SHE HAD EXTREME DROOPING OF HER RIGHT EYE. WHEN SHE TRIED TO STAND UP, SHE WAS VERY UNSTEADY AND REQUIRED ASSISTANCE TO WALK FROM A CHAIR TO HER BED. SHE DESCRIBED THE EVENT AS THE WORST MIGRAINE SHE HAS HAD WITH THE ADDITIONAL SYMPTOM OF THE PRESSURE IN HER UPPER HEAD. WITHIN A FEW HOURS, THE PRESSURE LESSENED SOMEWHAT BUT HER ACTIVITIES AND ABILITY TO FUNCTION NORMALLY ARE STILL IMPAIRED. SHE CONTACTED THE DOCTOR'S OFFICE AND THE NURSE FROM ENEURA ABOUT THE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674125 STMS MINI TRANSCRANIAL MAGNETIC STIMULATOR OKP ENEURA, INC. DWG-0500

    Patients

    Seq Age Sex Outcome Treatment
    1 Other