BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE SYSTEM

    MDR report key: 2962235 · Received February 14, 2013

    Report

    Report Number
    3005099803-2013-00901
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    January 22, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS IMPLANTED WITH AN ADVANTAGE FIT SYSTEM DURING A PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED COMPLICATIONS (SPECIFICS UNKNOWN). DURING THIS PROCEDURE, AN ADVANTAGE FIT SYSTEM WAS REPLACED WITH ANOTHER ONE PLACED MORE TOWARDS THE MIDDLE OF THE URETHRA. AT HER FOLLOW-UP APPOINTMENT IN (B)(6) 2011, THE PATIENT COMPLAINED OF URGENCY AND INCONTINENCE. THE PHYSICIAN PRESCRIBED ANTIBIOTICS AND REFERRED HER TO ANOTHER URO-GYNECOLOGIST FOR A SECOND OPINION REGARDING COMPLAINTS OF PERSISTENT FREQUENCY, SLOW URINE STREAM, AND SPASTIC-TYPE INCONTINENCE. THE SECOND PHYSICIAN PRESCRIBED OXYBUTYNIN. TESTS REVEALED MODERATE TO SEVERE CYSTOCELE AND MODERATE RECTOCELE; THE PHYSICIAN STATED THAT THE PATIENT HAD NOT FOLLOWED THE RECOMMENDED COURSE FOR EVALUATION TO TREAT THESE CONDITIONS. THE PATIENT WAS LAST SEEN ON (B)(6) 2012, AND STILL COMPLAINED OF FREQUENCY AND URGENCY. THE PHYSICIAN STARTED THE PATIENT ON A REGIMEN OF ESTROGEN CREAM. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64390 ADVANTAGE SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK557

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention