BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERYX PROCEDURE KIT

    MDR report key: 1328021 · Received March 3, 2009

    Report

    Report Number
    3005099803-2008-06338
    Event Type
    Injury
    Date Received
    March 3, 2009
    Date of Event
    February 23, 2005
    Report Date
    June 20, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION- MARLBOROUGH
    Product Code
    LMN
    PMA / PMN Number
    P020006
    Removal / Correction Number
    Z-0040-06
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CLINICAL STUDY: THE PRODUCT REMAINS IMPLANTED IN THE PATIENT; THEREFORE, A DEVICE EVALUATION CANNOT BE PERFORMED. NOTE: THE PRODUCT HAS BEEN REMOVED FROM THE GLOBAL MARKET IN 2005. BOSTON SCIENTIFIC CORPORATION NO LONGER PRODUCES THE REPORTED PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008 THAT AN ENTERYX DEVICE WAS IMPLANTED IN 2005 (PATIENT INFORMATION IS UKNOWN). IT WAS REPORTED THAT THE PATIENT HAD TWO SMALL ULCERS ABOVE THE GE JXN, CHEST PAIN, BURPING, ESOPHAGUS PAIN, AND GAS. THERE WERE NO DEVICE MALFUNCTIONS NOTED DURING THE TX. THE SUBJECT WAS NOTED TO HAVE A HIATAL HERNIA DURING THE TX ENDOSCOPIC ASSESSMENT. IT IS UNKNOWN IF THE ULCERS WERE RELATED TO THE ESOPHAGEAL PAIN.

    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 Other