BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYNX SYSTEM

    MDR report key: 16619984 · Received March 27, 2023

    Report

    Report Number
    3005099803-2023-01455
    Event Type
    Injury
    Date Received
    March 27, 2023
    Date of Event
    December 14, 2017
    Report Date
    March 27, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    UDI-DI
    08714729718949
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT WAS APPROXIMATED TO (B)(6) 2017, IMPLANT DATE, AS NO EVENT DATE WAS REPORTED. THIS EVENT WAS REPORTED BY THE PATIENT'S LEGAL REPRESENTATION. THE IMPLANT SURGEON IS: DR. (B)(6). (B)(6) HOSPITAL. (B)(6). IMDRF PATIENT CODE E211401 CAPTURES THE REPORTABLE EVENT OF SMALL BLADDER PUNCTURE.

    Description of Event or Problem · 0

    NOTE: THIS MANUFACTURER REPORT PERTAINS TO THE SECOND OF TWO DEVICES USE DURING DIFFERENT PROCEDURES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX SYSTEM DEVICE WAS IMPLANTED INTO THE PATIENT DURING A TRANSVAGINAL MESH RETROPUBIC SLING PLACEMENT + CYSTOSCOPY PROCEDURE PERFORMED ON (B)(6) 2017 TO TREAT STRESS URINARY INCONTINENCE. DURING THE OPERATION, LEFT TROCAR PLACEMENT WAS DIFFICULT. IT WAS REPOSITIONED AND PASSED AGAIN. UPON CYSTOURETHROSCOPY, THERE WAS A SMALL BLADDER PUNCTURE ON THE LEFT BUT NO TROCAR WAS PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555956 LYNX SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION M0068503000 0021093264 08714729718949

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Other