BEUDAMED
    FDA Adverse Event Death Summary report: N

    LYNX SYSTEM

    MDR report key: 2920970 · Received January 17, 2013

    Report

    Report Number
    3005099803-2013-00334
    Event Type
    Death
    Date Received
    January 17, 2013
    Report Date
    December 31, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS IMPLANTED WITH A LYNX SUPRAPUBIC MID-URETHRAL SLING SYSTEM ON (B)(6), 2009. AN AMS APOGEE DEVICE WAS ALSO IMPLANTED DURING THIS PROCEDURE.ACCORDING TO THE COMPLAINANT, THE PATIENT EXPIRED. THE DATE AND CAUSE OF DEATH WERE NOT PROVIDED. ACCORDING TO THE PHYSICIAN'S OFFICE, THE PATIENT HAS NOT RETURNED IN THREE YEARS, AND NO OTHER INFORMATION IS AVAILABLE. ALL OTHER INFORMATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26411 LYNX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK564

    Patients

    Seq Age Sex Outcome Treatment
    1 Death AMS APOGEE