BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYNX SYSTEM

    MDR report key: 2771187 · Received October 3, 2012

    Report

    Report Number
    3005099803-2012-04403
    Event Type
    Injury
    Date Received
    October 3, 2012
    Report Date
    September 10, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX SUPRAPUBIC SLING SYSTEM WAS IMPLANTED ON (B)(6), 2010.ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED URGENCY, URINE LEAKAGE, RECURRENT URINARY TRACT INFECTIONS, BLADDER PAIN, DYSURIA, INFECTION, DYSPAREUNIA, LEG PAIN, ABDOMINAL AND PELVIC PAIN.ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX SUPRAPUBIC SLING SYSTEM WAS IMPLANTED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED URGENCY, URINE LEAKAGE, RECURRENT URINARY TRACT INFECTIONS, BLADDER PAIN, DYSURIA, INFECTION, DYSPAREUNIA, LEG PAIN, ABDOMINAL AND PELVIC PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LYNX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068503000 1ML0011803

    Patients

    Seq Age Sex Outcome Treatment
    1 Other