BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOTRONIK EVIA DR-T

    MDR report key: 11957171 · Received June 7, 2021

    Report

    Report Number
    MW5101749
    Event Type
    Injury
    Date Received
    June 7, 2021
    Date of Event
    February 25, 2021
    Report Date
    June 4, 2021
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BIOTRONIK EVIA DR-T PACEMAKER'S DEFAULT MAGNET EFFECT IS TO TURN THE PACEMAKER TO 10 ASYNCHRONOUS BEATS AND THEN RETURN TO ITS SET MODE. ALL OTHER FDA APPROVED PACEMAKER'S DEFAULT MAGNET EFFECT IS TO TURN THE PACEMAKER TO ASYNCHRONOUS. FOR PERIOPERATIVE PACEMAKER MANAGEMENT THIS IS AN ISSUE SINCE PATIENT'S DO NOT ALWAYS KNOW WHAT TYPE OF PACEMAKER THEY HAVE. THIS PACEMAKER ACTUALLY GOT THROUGH OUR PREOPERATIVE PACEMAKER CLINIC'S RECOMMENDATIONS BECAUSE THEY THOUGHT THE MAGNET WOULD DEFAULT TO AN ASYNCHRONOUS MODE. THIS PATIENT WAS UNDER GENERAL ANESTHESIA AND WHEN THE MAGNET WAS APPLIED FOR HER SURGERY, IT WOULD NOT GO INTO AN ASYNCHRONOUS MODE FOR MORE THAN 10 BEATS. FOR MANY OPERATIVE PROCEDURES, PACEMAKER'S NEED TO BE SET TO ASYNCHRONOUS AND FOR THE BIOTRONIK PACEMAKER'S YOU MUST CALL EP TO REPROGRAM IT. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841280 BIOTRONIK EVIA DR-T PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ BIOTRONIK, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other| R