BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO 3000¿ CARDIAC ABLATION SYSTEM - POD

    MDR report key: 1981969 · Received February 8, 2011

    Report

    Report Number
    3001236349-2011-00006
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Report Date
    January 12, 2011
    Manufacturer
    STELLARTECH RESEARCH CORPORATION
    Product Code
    GXD
    PMA / PMN Number
    P020025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED AND PRODUCT INVESTIGATIONS WILL BE PERFORMED. THE INVESTIGATIONS RESULTS WILL BE SUBMITTED ON NEXT FOLLOW UP REPORT WHEN COMPLETED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITH NO CONSEQUENCES OR PATIENT COMPLICATIONS. RELATED TO MDR ID 3001236349-2011-00007. DEVICE NOT RECEIVED YET.

    Description of Event or Problem · 1

    DURING RF ABLATION, THE GENERATOR TURNED OFF SUDDENLY AND THEN TURNED BACK ON BY ITSELF WITH DIFFERENT PARAMETERS, THE PATIENT/PROCEDURE INFORMATION WAS NO LONGER IN THE MEMORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAESTRO 3000¿ CARDIAC ABLATION SYSTEM - POD GENERATOR, LESION, RADIOFREQUENCY - SYSTEM ACCESSORIES GXD STELLARTECH RESEARCH CORPORATION M00421870T0

    Patients

    Seq Age Sex Outcome Treatment
    1