BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANTAGE SYSTEM

    MDR report key: 2933796 · Received January 29, 2013

    Report

    Report Number
    3005099803-2013-00378
    Event Type
    Injury
    Date Received
    January 29, 2013
    Report Date
    January 4, 2013
    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

    NOTE: THIS MFR REPORT PERTAINS TO THE SECOND OF TWO DEVICES USED DURING THE SAME PROCEDURE. REFER TO ASSOCIATED MFR REPORT# 3005099803-2013-00377 FOR A DESCRIPTION OF THE OTHER DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A ADVANTAGE TRANSVAGINAL MID-URETHRAL SLING SYSTEM WAS IMPLANTED ON (B)(6) 2008. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT PRESENTED WITH UNSPECIFIED COMPLICATIONS. ACCORDING TO THE PHYSICIAN'S OFFICE, ON (B)(6) 2008, THE PATIENT WAS DIAGNOSED WITH ANTERIOR VAGINAL VAULT PROLAPSE AND FAILURE (SUBSEQUENT TO A FALL AFTER HER LAST SURGERY). NO COMPLICATIONS WERE REPORTED FOLLOWING THE IMPLANTATION OF THE DEVICE. ON (B)(6) 2008, DURING A POST-OPERATIVE MEDICAL APPOINTMENT, THE PATIENT WAS DOING WELL, YET REPORTED SOME INITIAL POST-OPERATIVE LOW RIGHT PELVIC PAIN. THE PATIENT REPORTED A PERSISTENT SENSE OF INCOMPLETE VOIDING. THE PATIENT WAS CATHETERIZED FOR 200 ML AFTER WAITING OVER AN HOUR. AN INCREASE IN HYDRATION WAS ADVISED AND A CALL TO THE PHYSICIAN IF PROBLEMS PERSISTED. THE PATIENT'S CONDITION WAS SUBSEQUENTLY REPORTED AS EXCELLENT WITH CUFF HEALING WELL. ON (B)(6) 2008, DURING A FINAL POST-OPERATIVE VISIT, THE PATIENT WAS VOIDING COMPLETELY, FREE OF PAIN, AND NO COMPLAINTS WERE REPORTED. ALL OTHER INFORMATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38879 ADVANTAGE SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK557

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PINNACLE ANTERIOR APICAL PELVIC FLOOR REPAIR KIT| XENFORM SOFT TISSUE REPAIR MATRIX