BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PACEMAKER

    MDR report key: 12252164 · Received July 29, 2021

    Report

    Report Number
    MW5102852
    Event Type
    Injury
    Date Received
    July 29, 2021
    Date of Event
    February 27, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    AFTER SOME INCIDENTS OF ARRHYTHMIA, WHEN MEDICATION DID NOT HELP, THE CARDIOLOGIST RECOMMENDED A PACEMAKER WHICH WAS IMPLANTED ON THE ABOVE DATE. THERE HAD BEEN NO WARNING GIVEN TO ME ABOUT THE FACT THAT THIS PACEMAKER WAS AN ELECTRONIC DEVICE THAT WOULD CONSTANTLY RADIATE AND COULD NOT BE TURNED OFF. I AM HIGHLY ALLERGIC TO AMF FIELDS AND HAD A BAD REACTION INSTANTLY. MY ALLERGY GOT WORSE AND WORSE OVER TIME AND I ASKED THE CARDIOLOGIST TO TURN THE PACEMAKER OFF. THAT'S WHEN I FOUND OUT THAT TURNING IT OFF IS IMPOSSIBLE, THE BATTERY CANNOT BE REMOVED, THE REMOVAL IS ONLY POSSIBLE BY AN ADDITIONAL SURGERY, AND NO CARDIOLOGIST I HAVE CONSULTED WANTS TO PERFORM THE REQUIRED SURGERY . THERE SHOULD HAVE BEEN A WARNING ON THE PART OF BOSTON SCIENTIFIC ALERTING THE DOCTOR THAT THE DEVICE IS CONTRAINDICATED FOR PEOPLE WITH HYPERSENSITIVITY TO ELECTRO-MAGNETIC WAVES. I HAVE BEEN SUFFERING FROM ALL THE SYMPTOMS OF EMF EXPOSURE, GETTING WORSE AND WORSE, HAD THE EMF EXPOSURE BEEN MENTIONED AT THE TIME BEFORE THE IMPLANT, OR THE IMPOSSIBILITY TO SHUT IT OFF, I WOULD NEVER HAVE CONSENTED TO THE SURGERY. BOSTON SCIENTIFIC GAVE NO WARNING. NOW I CANNOT GET RID OF THE DEVICE ON MY OWN AND NEED HELP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140749 PACEMAKER IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION L311

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention