BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KITS

    MDR report key: 2772176 · Received October 4, 2012

    Report

    Report Number
    3005099803-2012-04478
    Event Type
    Injury
    Date Received
    October 4, 2012
    Report Date
    September 10, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K071957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PINNACLE ANTERIOR APICAL PELVIC FLOOR REPAIR KIT WAS IMPLANTED ON AN UNKNOWN DATE. A LYNX SUPRAPUBIC SLING SYSTEM AND TWO XENFORM TISSUE REPAIR MATRICES WERE ALSO IMPLANTED. THE IMPLANTATION DATES PROVIDED ARE (B)(6) 2009 AND (B)(6) 2009, BUT IT WAS NOT SPECIFIED WHICH DEVICE/S WERE IMPLANTED ON EACH DATE. ACCORDING TO THE COMPLAINANT, POST-PROCEDURE, THE PATIENT EXPERIENCED URINARY PROBLEMS, PELVIC PAIN, ABDOMINAL PAIN, DYSPAREUNIA, BLEEDING, URINARY TRACT INFECTIONS, VAGINAL VAULT PROLAPSE AND STRESS URINARY INCONTINENCE. ALL OTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE PELVIC FLOOR REPAIR KITS MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317050

    Patients

    Seq Age Sex Outcome Treatment
    1 Other