BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 1980122 · Received February 7, 2011

    Report

    Report Number
    3005099803-2011-00315
    Event Type
    Malfunction
    Date Received
    February 7, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT SOLYX SINGLE INCISION SLING SYSTEM WAS USED DURING A SLING PROCEDURE.ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN HAD DIFFICULTY IMPLANTING THE MESH CARRIER ON THE PATIENT'S RIGHT SIDE. IT WAS REPORTED THAT THE MESH CARRIER DID NOT FALL OUT OF THE PATIENT'S TISSUE, BUT WOULD NOT "SEED CORRECTLY" INSIDE THE INTERNUS MUSCLE. THERE WERE NO ISSUES IMPLANTING THE MESH CARRIER ON THE LEFT SIDE. THE MESH WAS REMOVED FROM THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE WITH AN OBTRYX TRANSOBTURATOR MID-URETHRAL SLING SYSTEM. THERE WERE NO OTHER COMPLICATIONS DURING THE PROCEDURE AND THE PATIENT'S CURRENT CONDITION WAS REPORTED TO BE "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLYX SIS SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK660

    Patients

    Seq Age Sex Outcome Treatment
    1