BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYNX SYSTEM

    MDR report key: 1880413 · Received October 22, 2010

    Report

    Report Number
    3005099803-2010-04433
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    August 23, 2007
    Report Date
    October 3, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX SYSTEM WAS USED DURING AN UNKNOWN PROCEDURE PERFORMED ON (B)(6) 2007. ACCORDING TO THE COMPLAINANT, IMMEDIATELY POST PROCEDURE, THE PATIENT PRESENTED WITH SIGNIFICANT PAIN AND DIFFICULTY VOIDING. THE PATIENT WAS CATHETERIZED FOR A DURATION FOUR MONTHS AFTER THE PROCEDURE. MORE RECENTLY, THE PATIENT PASSED STOOL WITH WHAT APPEARED TO BE "A CLUMP OF" MESH FIBERS IN IT. ONCE THIS PASSED SHE WAS THEN AGAIN ABLE TO PASS STOOL. THE PATIENT IS CURRENTLY CATHETERIZED. IT WAS ALSO REPORTED THAT FOLLOW UP PHYSICIANS INDICATED POSSIBLE NERVE DAMAGE. THE PATIENT IS SCHEDULED TO HAVE THE SLING REMOVED ON (B)(6) 2010. IT WAS ALSO REPORTED THAT THERE WAS A DEVELOPMENT OF URETHRAL POLYPS, CHRONIC PAIN, PUDENDAL NEUROPATHY, NEUROGENIC BLADDER AND BOWEL DYSFUNCTION. (B)(4). THE REPORTED CATALOG AND LOT NUMBERS DO NOT MATCH ANY LYNX DEVICES. THE REPORTED CATALOG NUMBER IS 856300 AND THE REPORTED LOT NUMBER IS 0017042402. SEVERAL ATTEMPTS AT FOLLOW UP HAVE BEEN UNSUCCESSFUL.

    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 Other| R