BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE SYSTEM

    MDR report key: 2863330 · Received December 10, 2012

    Report

    Report Number
    3005099803-2012-05724
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    November 8, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TWO DIFFERENT IMPLANT DATES AND HOSPITALS WERE SUPPLIED: (B)(6), 2007 AND (B)(6), 2008, (B)(6). HOWEVER, IT WAS NOT IDENTIFIED WHICH PRODUCT WAS IMPLANTED ON WHICH DATE.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANTAGE FIT SYSTEM WAS IMPLANTED INTO THE PATIENT. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED INJURIES (SPECIFICS UNKNOWN).ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ACCORDING TO THE PHYSICIAN, THE PATIENT HAD PREVIOUSLY BEEN IMPLANTED WITH A GYNECARE PROLIFT AND PREFYX PPS SYSTEM BUT CONTINUED TO HAVE URINARY ISSUES. THE ADVANTAGE FIT SYSTEM WAS IMPLANTED ON (B)(6) 2008, THE PREFYX WAS LEFT IN PLACE AND THE PROLIFT WAS REMOVED. NO COMPLICATIONS WERE NOTED DURING THE ADVANTAGE IMPLANTATION. DURING FOLLOW UP IN 2009 AND 2011 THE PATIENT REPORTED NO ISSUES. IN (B)(6) 2012, THE PATIENT REPORTED LEAKAGE AND THAT FREQUENCY AND URGENCY HAD RETURNED. SHE WAS GIVEN A SAMPLE 5MG VESICARE BUT NEVER FILLED PRESCRIPTION. THE PHYSICIAN REPORTED THAT HE HAS NOT SEEN THE PATIENT SINCE (B)(6) 2012. ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTAGE SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK557

    Patients

    Seq Age Sex Outcome Treatment
    1 Other