BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE CAP

    MDR report key: 3902683 · Received June 30, 2014

    Report

    Report Number
    3005099803-2014-02339
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    July 8, 2013
    Report Date
    June 6, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K081739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. REPORTED EVENT OF JEJUNAL TUBE MIGRATION. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE TWO-PORT THROUGH THE PEG JEJUNAL TUBE WAS BEING USED FOR THE PURPOSE OF ADMINISTERING MEDICATION FOR ADVANCED STAGE PARKINSON¿S DISEASE. DATE OF JEJUNAL TUBE PLACEMENT IS UNKNOWN. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2013, THE JEJUNAL TUBE WAS DISPLACED. THE JEJUNAL TUBE NEEDED TO BE REPLACED SO THAT THE PATIENT CAN ADAPT TO DUODOPA TREATMENT. IT WAS REPORTED THAT THE PATIENT PREFERRED TO REMAIN IN THE HOSPITAL DURING DUODOPA ADAPTATION. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380680 ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE CAP TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER UNK443

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR DUODOPA