BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 2250207 · Received September 15, 2011

    Report

    Report Number
    3005099803-2011-03153
    Event Type
    Malfunction
    Date Received
    September 15, 2011
    Date of Event
    August 23, 2011
    Report Date
    August 23, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A SOLYX SINGLE INCISION SLING SYSTEM WAS USED DURING A SLING PROCEDURE. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN HAD DIFFICULTY TENSIONING THE SLING DURING PLACEMENT. IT WAS REPORTED THAT THE MIDLINE MARKER WAS AT THE MIDLINE POSITION UNDER THE URETHRA. AFTER BOTH SIDES HAD BEEN IMPLANTED, THE PHYSICIAN DETERMINED THAT THE SLING WAS PLACED TOO LOOSELY. THE SLING WAS REMOVED FROM THE PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER SOLYX SLING WITH NO COMPLICATIONS AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLYX SIS SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068507000 ML00000076

    Patients

    Seq Age Sex Outcome Treatment
    1