BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYNX SYSTEM

    MDR report key: 2830396 · Received November 13, 2012

    Report

    Report Number
    3005099803-2012-05287
    Event Type
    Injury
    Date Received
    November 13, 2012
    Report Date
    January 2, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED FROM PHONE CONVERSATION WITH PHYSICIAN ON (B)(4) 2013. EVENT DESCRIPTION UPDATED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX SUPRAPUBIC SLING SYSTEM WAS IMPLANTED ON (B)(6) 2006. ACCORDING TO THE PHYSICIAN, POST-PROCEDURE ON (B)(6) 2006, THE PATIENT COMPLAINED OF BACK PAIN. URINALYSIS WAS PERFORMED AND FOUND NEGATIVE FOR INFECTION. RENAL ULTRASOUND AND CAT SCAN WAS PERFORMED AND THE RESULTS WERE FOUND TO BE NORMAL. 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), 2006.ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT PRESENTED WITH UNSPECIFIED COMPLICATIONS.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 Other