BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LYNX SYSTEM

    MDR report key: 3120018 · Received May 20, 2013

    Report

    Report Number
    3005099803-2013-03701
    Event Type
    Injury
    Date Received
    May 20, 2013
    Report Date
    May 1, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN LYNX SUPRAPUBIC MID-URETHRAL SLING SYSTEM WAS IMPLANTED ON (B)(6) 2008. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT PRESENTED WITH UNSPECIFIED COMPLICATIONS. ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN ON (B)(6) 2013 STATED THAT THE PATIENT'S FIRST POST OPERATION VISIT WAS (B)(6) 2008 AND HAD NO COMPLICATIONS. ON (B)(6) 2012 THE PATIENT PRESENTED WITH CHRONIC CYSTITIS, TROUBLE EMPTYING HER BLADDER, RECURRENT URINARY TRACT INFECTIONS (UTI) AND INCONTINENCE. A RENAL ULTRASOUND WAS DONE, AS WELL AS A CYSTOSCOPY; BOTH CAME BACK NEGATIVE FOR ANY ABNORMALITIES. IN (B)(6) 2012 A URODYNAMIC TEST WAS DONE, WHICH CAME BACK NEGATIVE FOR ANY ABNORMALITIES. ON (B)(6) 2012 THE PATIENT COMPLAINED OF PAIN DURING INTERCOURSE. THE PHYSICIAN PRESCRIBED AN ESTROGEN COMPOUND CREAM FOR THE PAIN, AS WELL AS, VESICARE FOR HER BLADDER PROBLEMS. ON (B)(6) 2012 THE VESICARE AND CREAM WERE STATED TO BE HELPING THE PATIENT, HOWEVER, THE VERICARE WAS CHANGED TO OXYBUTYNIN DUE TO FINANCIAL REASONS. ON (B)(6) 2013 THE PATIENT STATED SHE WAS FEELING BETTER. THE PAIN DURING INTERCOURSE HAD IMPROVED AND SHE WAS EMPTYING HER BLADDER COMPLETELY. THE OXYBUTYNIN PRESCRIPTION WAS CHANGED TO TOVIAZ. 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
    221997 LYNX SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH UNK564

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention