BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KIT

    MDR report key: 1150489 · Received September 5, 2008

    Report

    Report Number
    3005099803-2008-04415
    Event Type
    Injury
    Date Received
    September 5, 2008
    Report Date
    August 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FTM
    PMA / PMN Number
    K071957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE IS UNK; CONSEQUENTLY, THE MFR AND EXPIRATION DATES CANNOT BE DETERMINED. 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 FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT ONE WEEK AFTER AN ANTERIOR PELVIC FLOOR REPAIR PROCEDURE USING A PINNACLE PFR KIT, THE PT EXPERIENCED URINARY RETENTION AND BUTTOCK AND BACK PAIN. ADDITIONALLY, A SUTURE BROKE AND EXPOSED THE ANTERIOR INCISION. THE PHYSICIAN CATHETERIZED THE PT FOR A WEEK AND SHE IS REPORTEDLY OUT OF RETENTION NOW. THE PT IS CURRENTLY TAKING PAIN MEDICATION AND ESTROGEN CREAM, AND WILL BE RESUTURED AT A LATER DATE.

    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 Required Intervention