BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOVIVE? JEJUNAL FEEDING TUBE

    MDR report key: 3951093 · Received July 22, 2014

    Report

    Report Number
    3005099803-2014-02532
    Event Type
    Injury
    Date Received
    July 22, 2014
    Report Date
    July 2, 2014
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K081739
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. THE JEJUNAL TUBE WAS KINKED. THE FOLLOWING WAS DONE TO TRY AND RESOLVE THE ISSUE FLUSHING, REPLACING PUMP, CHANGING BATTERIES, REPLACING CASSETTE. THESE ACTIONS DID NOT RESOLVE THE REPORTED ISSUE. A NEW JEJUNAL TUBE WAS PLACED. 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
    428345 ENDOVIVE? JEJUNAL FEEDING TUBE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00566380 15671612

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DUODOPA