BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYNX SYSTEM

    MDR report key: 3913354 · Received July 3, 2014

    Report

    Report Number
    3005099803-2014-02456
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    OTN
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT 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 USED DURING A HYSTERECTOMY WITH ANTERIOR AND POSTERIOR REPAIR BLADDER SUSPENSION PROCEDURE ON (B)(6), 2014. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BLADDER WAS PERFORATED. THE PATIENT WAS INSERTED WITH AN 18FR FOLEY CATHETER POST PROCEDURE. THE PATIENT WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389715 LYNX SYSTEM MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR OTN BOSTON SCIENTIFIC - MARLBOROUGH M0068503000 ML00002243

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR