BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KIT

    MDR report key: 1150486 · Received September 5, 2008

    Report

    Report Number
    3005099803-2008-04414
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    June 23, 2008
    Report Date
    August 6, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FTL
    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 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 CORPORATION 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. THE PHYSICIAN CATHETERIZED THE PT FOR A WEEK AND SHE WAS THEN OUT OF RETENTION. THE PT SUBSEQUENTLY SAW ANOTHER PHYSICIAN BECAUSE OF CONTINUED PAIN AND EXPOSED PINNACLE MESH. THIS PHYSICIAN OPERATED ON THE PT IN 2008, TO RELEASE THE LEFT SACROSPINOUS LIGAMENT MESH LEG, AND CUT OUT THE EXPOSED MESH. HE OPINED THAT THE MESH HAD BEEN PLACED TO TIGHTLY. THE PT IS REPORTEDLY DOING MUCH BETTER FOLLOWING THE CORRECTIVE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention