BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOVIVE? JEJUNAL FEEDING TUBE

    MDR report key: 4173978 · Received October 15, 2014

    Report

    Report Number
    3005099803-2014-03250
    Event Type
    Malfunction
    Date Received
    October 15, 2014
    Report Date
    September 22, 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. (B)(4). 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 TO ADMINISTER MEDICATION FOR THE 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.

    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 TO ADMINISTER MEDICATION FOR THE 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. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2014: THE EXACT PROCEDURE DATE IS UNKNOWN HOWEVER, THE JEJUNAL TUBE HAS BEEN IN PLACE FOR 5 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654223 ENDOVIVE? JEJUNAL FEEDING TUBE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00566380

    Patients

    Seq Age Sex Outcome Treatment
    1 DUODOPA