BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOVIVE? JEJUNAL FEEDING TUBE

    MDR report key: 4110875 · Received September 23, 2014

    Report

    Report Number
    3005099803-2014-03106
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 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

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE SUSPECT DEVICE LOT NUMBER; THEREFORE, THE LOT EXPIRATION AND DEVICE MANUFACTURE DATES ARE UNKNOWN. (B)(4) JEJUNAL TUBE BLOCKED/OCCLUDED. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT IS IMPLANTED IN THE PATIENT; 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铠DISEASE. PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, THE JEJUNAL TUBE WAS DIFFICULT TO RINSE. 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. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 16, 2014: THE EXACT PROCEDURE DATE IS UNKNOWN, HOWEVER, THE JEJUNAL TUBE HAS BEEN IN PLACE SINCE JUNE 2014. THE JEJUNAL TUBE WAS REPLACED WITH A NEW ENDOVIVE TWO-PORT THROUGH THE PEG JEJUNAL TUBE.

    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. PROCEDURE DATE IS UNKNOWN. ACCORDING TO THE COMPLAINANT, THE JEJUNAL TUBE WAS DIFFICULT TO RINSE. 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
    591632 ENDOVIVE? JEJUNAL FEEDING TUBE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00566380

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other DUODOPA