BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NERVE REGULATOR.

    MDR report key: 13771772 · Received March 14, 2022

    Report

    Report Number
    MW5108167
    Event Type
    Injury
    Date Received
    March 14, 2022
    Date of Event
    January 28, 2019
    Report Date
    March 14, 2022
    Manufacturer
    UNKNOWN
    Product Code
    NHI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    PATIENT CALLED TO REPORT SERIOUS ADVERSE EVENTS INVOLVING A DEVICE HE SAYS WAS IMPLANTED IN HIM WITHOUT HIS KNOWLEDGE OR APPROVAL. PATIENT STATED THE DEVICE IS NOT YET APPROVED BY THE FDA AND IS UNDER INVESTIGATION FOR USE IN PEOPLE WITH PARALYSIS OR NERVE DAMAGE. PATIENT STATED HE WAS STABBED 5 TIMES AND DURING SURGERY DUE TO THE STABBINGS HE BELIEVES A DEVICE WAS IMPLANTED IN HIM WITHOUT HIS PERMISSION AND UNLAWFULLY. PATIENT STATED THE CHIP THAT WAS IMPLANTED IS ATTACHED TO HIS NERVES AND HAS HARDWARE THAT CONTROLS IT. PATIENT STATED THE PEOPLE WHO CONTROL HIS DEVICE ARE EXPERIMENTING ON HIM AND CAUSING HIM SEVERE PAIN AND ARE TORTURING HIM AND HE IS AFRAID FOR HIS LIFE. PATIENT STATED HE HAS PROBLEMS WITH URINATING AND BOWL MOVEMENTS. PATIENT STATED HIS LIFE IS THREATENED IF HE CALLS TO REPORT ON THE DEVICE WHOEVER IS CONTROLLING IT DOES NOT WANT TO BE EXPOSED. PATIENT STATED THIS IS AN URGENT SITUATION FOR HIM, IT'S A MATTER OF LIFE AND DEATH AND HE NEEDS HELP AND ASSISTANCE ASAP!

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42541 NERVE REGULATOR. STIMULATOR, NERVE, ELECTRICAL, PERCUTANEOUS (PENS), FOR PAIN RELIEF. NHI UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male Other