BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYNX SYSTEM

    MDR report key: 2880293 · Received December 19, 2012

    Report

    Report Number
    3005099803-2012-06228
    Event Type
    Injury
    Date Received
    December 19, 2012
    Report Date
    November 27, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX SUPRAPUBIC SLING SYSTEM WAS IMPLANTED ON (B)(6), 2011. ACCORDING TO THE PHYSICIAN'S OFFICE, POST-PROCEDURE, NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS GIVEN MEDICATION (TYPE OF MEDICATION UNSPECIFIED) TO TREAT URINARY TRACT INFECTIONS AND FREQUENT URINATION. PER THE PHYSICIAN, THE PATIENT IS NO LONGER SUFFERING FROM STRESS URINARY INCONTINENCE DUE TO THE DEVICE ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LYNX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK564

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention