BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KIT

    MDR report key: 1150263 · Received September 3, 2008

    Report

    Report Number
    3005099803-2008-04310
    Event Type
    Injury
    Date Received
    September 3, 2008
    Date of Event
    July 16, 2008
    Report Date
    August 4, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FTM
    PMA / PMN Number
    K071957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE DEVICE IS UNK; CONSEQUENTLY, THE EXPIRATION DATE OF THE DEVICE IS UNK. THE LOT NUMBER OF THE DEVICE IS UNK; CONSEQUENTLY, THE MANUFACTURE DATE OF THE DEVICE IS UNK. THE COMPLAINANT INDICATED THAT THE DEVICE WAS IMPLANTED AND WILL NOT BE RETURNED FOR EVAL; THEREFORE, A FAILURE ANALYSIS CANNOT BE PERFORMED, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP. THAT FOLLOWING AN ANTERIOR PELVIC FLOOR REPAIR PROCEDURE USING A PINNACLE PFR KIT, THE PT EXPERIENCED SIGNIFICANT LEG PAIN. THE PHYSICIAN DID NOT FIND AN OBVIOUS CAUSE FOR THE PAIN. THE PT IS SEEING A PAIN SPECIALIST, AND IS REPORTEDLY IN "STABLE" CONDITION.

    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