BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYNX SYSTEM

    MDR report key: 1760120 · Received July 16, 2010

    Report

    Report Number
    3005099803-2010-03247
    Event Type
    Injury
    Date Received
    July 16, 2010
    Report Date
    June 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX SYSTEM WAS USED DURING A TVT PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN HIT AN ARTERY WHILE ADVANCING THE DELIVERY DEVICE. EXCESS BLEEDING OCCURRED AND THE PROCEDURE WAS NOT COMPLETED. THE PATIENT WAS HOSPITALIZED AND HAD ATYPICAL ANATOMY IN THE PELVIC REGION. A NEURORADIOLOGIST WAS CALLED IN TO HELP REPAIR THE ARTERY AND STOP THE BLEEDING. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "STABLE" AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LYNX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068503001

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O