BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOBLATE ABLATION SYSTEM

    MDR report key: 486472 · Received September 24, 2003

    Report

    Report Number
    2135394-2003-00004
    Event Type
    Malfunction
    Date Received
    September 24, 2003
    Date of Event
    August 26, 2003
    Report Date
    August 26, 2003
    Manufacturer
    MEDTRONIC CARDIAC SURGERY TECHNOLOGIES
    Product Code
    ---
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE UNIT WAS NOT FUNCTIONAL AND DISPLAYED AN INTERNAL POWER SUPPLY ERROR MESSAGE THAT COULD NOT BE CLEARED. NO BACK-UP UNIT WAS AVAILABLE AND THE ABLATION PROCEDURE COULD NOT BE PERFORMED. NO ADDITIONAL PT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOBLATE ABLATION SYSTEM BIPOLAR ABLATION GENERATOR --- MEDTRONIC CARDIAC SURGERY TECHNOLOGIES 60890 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other