BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLYX SIS SYSTEM

    MDR report key: 19575571 · Received June 20, 2024

    Report

    Report Number
    2124215-2024-37363
    Event Type
    Malfunction
    Date Received
    June 20, 2024
    Date of Event
    June 5, 2024
    Report Date
    June 20, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    PAH
    UDI-DI
    08714729774044
    PMA / PMN Number
    K081275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: DEVICE CODE A040609 CAPTURES THE REPORTABLE EVENT OF THE SHAFT TIP BENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SOLYX SIS SYSTEM IMPLANT PROCEDURE, THE DEVICE WAS ADVANCED INTO THE PATIENT, HOWEVER, THE SHAFT TIP WAS OBSERVED TO BE BENT. THE DEVICE WAS REMOVED, AND ANOTHER SOLYX SIS SYSTEM DEVICE WAS USED TO COMPLETE THE PROCEDURE AND NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2155852 SOLYX SIS SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA PAH BOSTON SCIENTIFIC CORPORATION M0068507000 0029430675 08714729774044

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female