BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERYX PROCEDURE KIT

    MDR report key: 1324963 · Received February 25, 2009

    Report

    Report Number
    3005099803-2008-02884
    Event Type
    Injury
    Date Received
    February 25, 2009
    Date of Event
    February 25, 2004
    Report Date
    June 6, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION- MARLBOROUGH
    Product Code
    LMN
    PMA / PMN Number
    P020006
    Removal / Correction Number
    Z-0040-06
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER (PAIN WITH SWALLOWING). THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN.THE DEVICE REMAINS IMPLANTED IN THE PATIENT; THEREFORE, A DEVICE EVALUATION CANNOT BE PERFORMED. NOTE: THIS PRODUCT WAS REMOVED FROM THE GLOBAL MARKET IN 2005. BOSTON SCIENTIFIC CORPORATION NO LONGER PRODUCES THE REPORTED PRODUCT. PRODUCT UNAVAILABLE FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2007 THAT AN ENTERYX PROCEDURE KIT WAS IMPLANTED IN A FEMALE PATIENT (WEIGHT UNKNOWN) IN 2004. ACCORDING TO THE COMPLAINANT, A WEEK OR SO AFTER HAVING THE PROCEDURE, SHE "STARTED NOT FEELING WELL. SHE HAD A FEVER AND PAIN IN HER CHEST. THIS WENT ON FOR MANY MONTHS AND SEVERAL DOCTOR VISITS, AND EVENTUALLY SHE HAD A CT SCAN THAT SHOWED ENTERYX IN HER LUNGS. SHE HAS SEEN A FEW DOCTORS, AND HAS BEEN TOLD SHE WILL HAVE TO LIVE WITH IT. SHE TAKES MEDICINE EVERYDAY AND IS HOARSE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERYX PROCEDURE KIT CERAMICS, CALCIUM TRIPHOSPHATE/HYDROXYPATITE, NON-LOAD BEARING USES LMN BOSTON SCIENTIFIC CORPORATION- MARLBOROUGH M00572600

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other