BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEX 10

    MDR report key: 508814 · Received January 26, 2004

    Report

    Report Number
    3003468702-2004-00001
    Event Type
    Injury
    Date Received
    January 26, 2004
    Report Date
    January 26, 2004
    Manufacturer
    AFX INC.
    Product Code
    NEY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 01/2004, DURING A SURGICAL CONFERENCE, THE SPEAKING SURGEON STATED THAT THREE MONTHS FOLLOWING A MITRAL VALVE REPLACEMENT PROCEDURE, CONCOMITANT TO AN ABLATION PROCEDURE, HIS PT PRESENTED WITH CORONARY DISEASE AND REQUIRED PLACEMENT OF A STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEX 10 MICROWAVE ABLATION NEY AFX INC. 102008-05 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention MITRAL VALVE REPLACEMENT - RIGHT THORACOTOMY.