BEUDAMED
    FDA Adverse Event Death Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KIT

    MDR report key: 1312380 · Received February 12, 2009

    Report

    Report Number
    3005099803-2009-00541
    Event Type
    Death
    Date Received
    February 12, 2009
    Date of Event
    January 3, 2009
    Report Date
    January 16, 2009
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FTM
    PMA / PMN Number
    K071957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE OF THIS EVENT. THE PHYSICIAN REQUESTED A COPY OF THE AUTOPSY REPORT FROM THE CORONER'S OFFICE, WHICH SHE WILL FORWARD TO BOSTON SCIENTIFIC. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED, WHEN BOSTON SCIENTIFIC RECEIVES A COPY OF THE AUTOPSY REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT DURING AN ANTERIOR PELVIC FLOOR REPAIR PROCEDURE IN 2008 USING A PINNACLE PFR KIT, THE PHYSICIAN ALSO PERFORMED A HYSTERECTOMY, AN OOPHORECTOMY, A PERINEOPLASTY, AND A SLING PROCEDURE. ALL APPEARED TO GO WELL, WITH NO TENDERNESS TO THE EXTREMITIES AND NO STENOSIS. COMPRESSION STOCKINGS WERE USED. THE PT WAS DOING WELL, VITALS WERE GOOD AND URINE WAS CLEAN. THE ONLY COMPLAINT WAS LOWER BACK PAIN, WHICH THE PHYSICIAN ATTRIBUTED TO FIBROMYALGIA. THE PT WAS RELEASED IN 2009, COLLAPSED SHORTLY AFTER GETTING HOME, AND EXPIRED. THE PHYSICIAN STATED SHE DOES NOT FEEL THE PINNACLE DEVICE OR PINNACLE PROCEDURE WERE TO BLAME FOR THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE PELVIC FLOOR REPAIR KIT FTM BOSTON SCIENTIFIC CORPORATION M0068317050 0ML8111101

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death