BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYNX SYSTEM

    MDR report key: 3180802 · Received June 20, 2013

    Report

    Report Number
    3005099803-2013-04942
    Event Type
    Injury
    Date Received
    June 20, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX SUPRAPUBIC MID-URETHRAL SLING SYSTEM WAS IMPLANTED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE PATIENT EXPERIENCED AN UNKNOWN INJURY. ACCORDING TO THE PHYSICIAN¿S OFFICE, THE PATIENT WAS SEEN IN (B)(6) 2012 AND COMPLAINED OF RECURRENT INCONTINENCE AND URINARY LEAKAGE AND PAIN DURING INTERCOURSE. IN (B)(6) 2012, THE PATIENT WAS SEEN AGAIN AND HAD THE SAME COMPLAINTS. THE PATIENT WAS EXAMINED AND THE PHYSICIAN DID NOT IDENTIFY ANY PROBLEMS. THE PATIENT WAS REFERRED TO A SPECIALIST AND HAS NOT BEEN SEEN SINCE. ALL OTHER INFORMATION IS UNKNOWN. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279587 LYNX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK564

    Patients

    Seq Age Sex Outcome Treatment
    1 Other