BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT ELECTROPHYSIOLOGY

    MDR report key: 5662239 · Received May 14, 2016

    Report

    Report Number
    MW5062335
    Event Type
    Malfunction
    Date Received
    May 14, 2016
    Report Date
    May 14, 2016
    Manufacturer
    ABBOTT
    Product Code
    MTD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE ABBOTT ELECTROPHYSIOLOGY RHYTHMVIEW SYSTEM COMBINED WITH FIRMAP IS THE ONLY MAPPING SYSTEM THAT SPECIFICALLY TELLS AN OPERATOR WHERE TO ABLATE. THE VALIDITY OF THIS IS NOW CAST IN SERIOUS DOUBT BASED ON THE RECENTLY ANNOUNCED OASIS DATA. THIS SYSTEM IS NOW INSTRUCTING DOCTORS TO INTENTIONALLY DAMAGE THE HEART VIA ABLATION IN AREAS THAT DO NOT REQUIRE BEING DAMAGED. BY MAKING PROCEDURES TAKE LONGER AND INSTRUCTING OPERATORS TO BURN THE HEART WHERE IT DOES NOT NEED TO BE BURNED, THE FDA IS ALLOWING A MEDICAL DEVICE TO BE MARKETED IN A WAY THAT WILL LIKELY RESULT IN HARM AND DEATH. THERE IS NO DOUBT THIS SYSTEM INSTRUCTS DOCTORS TO BURN THE HEART IN A WAY THAT SPECIFICALLY CONTRADICTS ALL OF THE US AND INTERNATIONAL SOCIETY GUIDELINES AND NOW PEER REVIEWED CLINICAL TRIAL DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310358 ABBOTT ELECTROPHYSIOLOGY RHYTHMVIEW AND FIRMAP MTD ABBOTT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other