BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 2063198 · Received April 19, 2011

    Report

    Report Number
    3005099803-2011-01266
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S EXACT AGE IS UNKNOWN, HOWEVER, IT WAS REPORTED THAT THE PATIENT IS (B)(6).

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWED NO EVIDENCE OF A MANUFACTURING RELATED POTENTIAL CAUSE FOR THIS EVENT. A VISUAL AND FUNCTIONAL ANALYSIS OF THE RETURNED DEVICE REVEALED NO DEFECTS. BOTH MESH CARRIERS FIT EASILY ONTO THE DELIVERY DEVICE. OPERATIONAL CONTEXT CONTRIBUTED TO THIS EVENT.

    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 PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, WHEN THE PHYSICIAN ATTEMPTED TO IMPLANT THE FIRST SIDE OF THE SLING, THE MESH CARRIER WOULD NOT ENGAGE THE PATIENT'S TISSUE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER SOLYX SINGLE INCISION SLING SYSTEM AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "FINE."

    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 PLACEMENT PROCEDURE. ACCORDING TO THE COMPLAINANT, WHEN THE PHYSICIAN ATTEMPTED TO IMPLANT THE FIRST SIDE OF THE SLING, THE MESH CARRIER WOULD NOT ENGAGE THE PATIENT'S TISSUE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER SOLYX SINGLE INCISION SLING SYSTEM AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE 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 M0068507000 1ML0071501

    Patients

    Seq Age Sex Outcome Treatment
    1