BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYNX SYSTEM

    MDR report key: 12167171 · Received July 14, 2021

    Report

    Report Number
    3005099803-2021-03517
    Event Type
    Injury
    Date Received
    July 14, 2021
    Date of Event
    May 10, 2019
    Report Date
    July 14, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OTN
    UDI-DI
    08714729718949
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS WAS REPORTED BY THE PATIENT. THE HEALTHCARE FACILITY IS: (B)(6). HEALTH (B)(4) INCIDENT REPORT REFERENCE NO. (B)(4); SUBMITTED TO HEALTH (B)(6) BY THE PATIENT. (B)(4). THE DEVICE WAS IMPLANTED AND IS NOT EXPECTED TO BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX SUPRAPUBIC MID-URETHRAL SLING SYSTEM WAS IMPLANTED INTO THE PATIENT DURING A PROCEDURE PERFORMED ON (B)(6) 2019. ON (B)(6) 2019, THE PATIENT BEGAN TO EXPERIENCE PAIN IN THE URETHRA AND DIFFICULTY EMPTYING HER BLADDER. THE PATIENT ALSO REPORTED THAT SEXUAL INTERCOURSE IS NOT POSSIBLE AND WANTS THE DEVICE REMOVED. THE PATIENT IS EXPECTING TO SEE A SPECIALIST AT THE CHUM FOR THE COMPLETE REMOVAL. THE PATIENT WAS TOLD BY A PHYSICIAN FROM ST EUSTACHE THAT SHE WILL BE INCONTINENT FOR LIFE SINCE IT IS IN HER URETHRA, SHE WAS TOLD THAT SHE DOES NOT HAVE TO REMOVE IT, AS SOON AS SHE'LL HAVE URINE IN THE BLADDER IT'LL EMPTY AUTOMATICALLY. SHE HOPES THAT THE SPECIALIST AT THE CHUM WILL HAVE BETTER NEWS AND THAT IT WILL NOT HAPPEN AND HOW THE DOCTOR DID NOT ADVISE THEM OF THE REAL DANGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064710 LYNX SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC CORPORATION M0068503000 0021807482 08714729718949

    Patients

    Seq Age Sex Outcome Treatment
    1 Other