BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYNX SYSTEM

    MDR report key: 2922835 · Received January 18, 2013

    Report

    Report Number
    3005099803-2013-00291
    Event Type
    Injury
    Date Received
    January 18, 2013
    Report Date
    December 31, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT RETURNED FOR A POST-OPERATIVE VISIT ON (B)(6) 2007, AND REPORTED THAT SHE CONTINUED TO HAVE INCONTINENCE. SHE WAS CATHETERIZED THE SAME DAY IN ORDER TO DECREASE PAD USAGE. THE PHYSICIAN THEN REFERRED THE PATIENT TO ANOTHER PHYSICIAN AT THE SAME CLINIC. THE PATIENT'S CURRENT CONDITION AND ALL OTHER INFORMATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LYNX SUPRAPUBIC SLING SYSTEM WAS IMPLANTED ON (B)(6) 2007. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT PRESENTED WITH UNSPECIFIED COMPLICATIONS. ACCORDING TO THE PHYSICIAN'S OFFICE, THE PATIENT DID NOT ATTEND A FOLLOW UP APPOINTMENT SCHEDULED ON (B)(6) 2008. 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
    27663 LYNX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK564

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other| R