BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOTERIX 1X1 MINI-CT

    MDR report key: 18374964 · Received December 20, 2023

    Report

    Report Number
    MW5149445
    Event Type
    Injury
    Date Received
    December 20, 2023
    Date of Event
    November 27, 2023
    Report Date
    December 18, 2023
    Manufacturer
    SOTERIX MEDICAL, INC.
    Product Code
    EGJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS USING A TRANSCRANIAL DIRECT CURRENT STIMULATION DEVICE TO POTENTIALLY TREAT NEUROLOGICAL SYMPTOMS RELATED TO LONG COVID AS PART OF THE RECOVER-NEURO STUDY (ACCORDING TO THE STUDY PROTOCOL, IT WAS A SOTERIX 1X1 MINI-CT DEVICE). I'VE HAD LONG COVID FOR NEARLY TWO YEARS, AFTER GETTING COVID IN (B)(6) 2022. I ALSO HAVE GENERALIZED EPILEPSY - I WAS CLEARED FOR THE TDCS(TRANSCRANIAL DIRECT-CURRENT STIMULATION) TREATMENT BECAUSE I'VE ONLY HAD TWO INSTANCES OF LOSING CONSCIOUSNESS BELIEVED TO BE SEIZURES (BUT NO CONFIRMED TO BE SEIZURES) IN APRIL AND (B)(6) 2021 (SUBSEQUENT EEGS(ELECTROENCEPHALOGRAMS) FOUND EPILEPTOGENIC ACTIVITY, PRIMARILY WHILE SLEEPING). AS MENTIONED, I ALSO HAVE LONG COVID, WHERE MY PRIMARY SYMPTOMS ARE BRAIN FOG, FATIGUE, POSTEXERTIONAL MALAISE, DISTURBED SLEEP, AND TINNITUS. WITHIN A WEEK OF STARTING THE TDCS, I STARTED HAVING SPELLS OF SEVERE DIZZINESS, MUSCLE SPASMS WHEN ATTEMPTING TO FALL ASLEEP, AND WORSENED INSOMNIA. I STAYED ON THE TDCS FOR TWO WEEKS, AND WHEN I STOPPED, THE SPELLS OF DIZZINESS AND MUSCLE SPASMS FADED OVER THE COURSE OF A FEW DAYS. THE WORSENED SLEEP QUALITY HAS REMAINED FOR AT LEAST THREE WEEKS. GIVEN THE TIMING OF THE SYMPTOMS, AND THE FACT THAT I HAVE NOT HAD SYMPTOMS LIKE THIS IN THE TWO YEARS I'VE HAD LONG COVID, NOR IN THE ALMOST THREE YEARS I'VE HAD EPILEPSY, I STRONGLY SUSPECT THAT THESE SYMPTOMS WERE TRIGGERED BY AN INTERACTION WITH THE TDCS DEVICE AND MY EPILEPSY AND/OR LONG COVID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297412 SOTERIX 1X1 MINI-CT DEVICE, IONTOPHORESIS, OTHER USES EGJ SOTERIX MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male FAMOTIDINE 20MG TWICE DAILY (40MG TOTAL).| FEXOFENADINE 180MG TWICE DAILY (360MG TOTAL).| GUANFACINE ER 2MG.| LOW-DOSE NALTREXONE 2MG.| MELATONIN 3MG.| MONTELUKAST 10MG.| N-ACETYL-CYSTEINE 600MG.| ROSUVASTATIN 20MG.| VITAMIN D 5,000 UNITS.