BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSITE X EP SYSTEM

    MDR report key: 12432739 · Received September 7, 2021

    Report

    Report Number
    2184149-2021-00259
    Event Type
    Malfunction
    Date Received
    September 7, 2021
    Date of Event
    August 16, 2021
    Report Date
    September 22, 2021
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DQK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. IN ADDITION, NO LOG FILES WERE RECEIVED. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    DURING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE, THE HDG CATHETER INTERRUPTED THE VOXEL RECORDING FOR NO APPARENT REASON. AFTER SWITCHING TO NAVX MODE, ALL CATHETERS JUMPED UP AND DOWN ABOUT A CENTIMETER IN AN UNCONTROLLED MANNER. SINCE THE PROBLEM COULD NOT BE RESOLVED, THE PROCEDURE WAS ABORTED. THE PATIENT WAS STABLE BEFORE AND AFTER THE EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329286 ENSITE X EP SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK ST. JUDE MEDICAL ENSITE-SYSTEM-01

    Patients

    Seq Age Sex Outcome Treatment
    1