BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KIT

    MDR report key: 1242948 · Received November 21, 2008

    Report

    Report Number
    3005099803-2008-06686
    Event Type
    Injury
    Date Received
    November 21, 2008
    Report Date
    October 24, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FTM
    PMA / PMN Number
    K071957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS NOT ABLE TO PROVIDE THE LOT NUMBER OF THE SUSPECT DEVICE; THEREFORE, THE DEVICE EXPIRATION AND MANUFACTURE DATES ARE UNKNOWN. SINCE THE DEVICE REMAINS IMPLANTED, AND WILL NOT BE RETURNED, A FAILURE ANALYSIS IS NOT AVAILABLE, AND THE RELATIONSHIP BETWEEN THIS DEVICE, AND THE CAUSE OF THIS EVENT IS UNDETERMINED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY 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

    NOTE: THE DATE OF THE EVENT IS UNKNOWN. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON OCTOBER 24, 2008, THAT A PINNACLE PELVIC FLOOR REPAIR KIT WAS USED DURING AN ANTERIOR AND POSTERIOR FLOOR REPAIR PROCEDURE. PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, APPROXIMATELY FOUR MONTHS AGO, THE PATIENT HAD A PFR PROCEDURE. EXACTLY THREE MONTHS AFTERWARDS, SHE PRESENTED WITH A SMALL AMOUNT OF VAGINAL BLEEDING. EXAMINATION REVEALED A 1-CM MESH EXPOSURE IN THE POSTERIOR VAGINAL WALL, WITH NO INFLAMMATION OR INFECTION. THE MESH WAS TRIMMED, AND THE PATIENT IS NOW COMPLETELY HEALED. THE CAUSE FOR THE EXPOSURE IS UNKNOWN.

    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 67 YR Other