BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KIT

    MDR report key: 1242935 · Received November 21, 2008

    Report

    Report Number
    3005099803-2008-06692
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 17, 2008
    Report Date
    October 22, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FTM
    PMA / PMN Number
    K071957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMPLANTED DATE OF 2008, IS AN APPROXIMATION. THE LOT NUMBER IS NOT KNOWN; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE CANNOT BE DETERMINED. THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT APPROXIMATELY THREE WEEKS AFTER A PINNACLE DEVICE WAS IMPLANTED, THE PATIENT COMPLAINED OF A FEVER, A LITTLE PAIN, AND POSSIBLY A BLADDER INFECTION. UPON EXAMINATION, THE PHYSICIAN NOTED THAT THE SUTURE LINE HAD NOT HEALED, AND THERE WAS A MESH EXPOSURE ABOUT A HALF-CENTIMETER WIDE BY ONE-AND-A-HALF CENTIMETERS LONG. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND POSSIBLY ESTROGEN CREAM, ADN THE DOCTOR DECIDED TO WAIT TO CLOSE THE INCISION IN CASE THERE IS AN INFECTION. NO FURTHER INFORMATION ABOUT THIS CASE HAS BEEN FORTHCOMING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK