BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADVANTAGE SYSTEM

    MDR report key: 2778937 · Received October 9, 2012

    Report

    Report Number
    3005099803-2012-04528
    Event Type
    Death
    Date Received
    October 9, 2012
    Report Date
    September 12, 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 ADVANTAGE TRANSVAGINAL MID-URETHRAL SLING SYSTEM WAS IMPLANTED DURING A TVT PROCEDURE. ACCORDING TO THE PHYSICIAN, THE PATIENT WAS NOT SEEN FOR A YEAR POST-IMPLANTATION AND HAD NO ISSUES OR COMPLICATIONS DURING THAT TIME. SOMETIME IN 2007, THE PATIENT PRESENTED WITH CONTINUED STRESS URINARY INCONTINENCE AND ONE OR TWO BLADDER INFECTIONS. THE PHYSICIAN DOES NOT KNOW WHETHER THE ADVANTAGE DEVICE CONTRIBUTED TO EITHER OF THESE COMPLICATIONS. THE PHYSICIAN HAS NO KNOWLEDGE OF ANY PAIN OR DISABILITY, AND WAS UNAWARE THAT THE PATIENT HAD EXPIRED. HE DOES NOT KNOW THE CAUSE OF DEATH, BUT OPINED THAT IT WAS NOT RELATED TO THE ADVANTAGE DEVICE. ALL OTHER INFORMATION IS REPORTEDLY UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE TRANSVAGINAL MID-URETHRAL SLING SYSTEM WAS IMPLANTED ON (B)(6) 2006. ACCORDING TO THE COMPLAINANT, THE PATIENT SUFFERED PAIN, DISABILITY, AND HAS PASSED AWAY AS A RESULT OF THE IMPLANTATION OF THE PRODUCT. THE PATIENT EXPIRED ON (B)(6) 2011. ALL OTHER INFORMATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTAGE SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068502000 0ML6012305

    Patients

    Seq Age Sex Outcome Treatment
    1 Death