BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOVIVE? JEJUNAL FEEDING TUBE

    MDR report key: 3833879 · Received May 27, 2014

    Report

    Report Number
    3005099803-2014-02089
    Event Type
    Injury
    Date Received
    May 27, 2014
    Report Date
    April 30, 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).THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND 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.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ENDOVIVE JEJUNAL FEEDING TUBE WAS BEING USED FOR THE PURPOSE OF ADMINISTERING MEDICATION FOR ADVANCED STAGE PARKINSON¿S DISEASE. DATE OF JEJUNAL TUBE PLACEMENT IS UNKNOWN, HOWEVER, IT WAS REPORTED THAT THE JEJUNAL TUBE HAD BEEN IN PLACE FOR 9 MONTHS. ACCORDING TO THE COMPLAINANT, DURING A PLANNED REPLACEMENT OF THE JEJUNAL TUBE, A BEZOAR AND GASTRODUODENAL ULCERS WERE DISCOVERED IN THE PATIENT. THE JEJUNAL TUBE WAS REMOVED AND THE PATIENT IS AWAITING FOR POSITIONING OF A NEW JEJUNAL TUBE. 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 JEJUNAL FEEDING TUBE WAS BEING USED FOR THE PURPOSE OF ADMINISTERING MEDICATION FOR ADVANCED STAGE PARKINSON'S DISEASE. DATE OF JEJUNAL TUBE PLACEMENT IS UNKNOWN, HOWEVER, IT WAS REPORTED THAT THE JEJUNAL TUBE HAD BEEN IN PLACE FOR 9 MONTHS. ACCORDING TO THE COMPLAINANT, DURING A PLANNED REPLACEMENT OF THE JEJUNAL TUBE, A BEZOAR AND GASTRODUODENAL ULCERS WERE DISCOVERED IN THE PATIENT. THE JEJUNAL TUBE WAS REMOVED AND THE PATIENT IS AWAITING FOR POSITIONING OF A NEW JEJUNAL TUBE. 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 MAY 30, 2014: THE PROCEDURE DATE IS (B)(6) 2013. THE INFUSION THERAPY WAS STARTED IN (B)(6) 2011. THE FITOBEZOAR DEPOSIT WAS LOCATED AT THE TIP OF THE JEJUNAL TUBE AND TRACTION. THE DECUBITUS ULCER WAS LOCATED AT THE PYLORUS AND ALONG THE DUODENAL C. AS A RESULT OF THE EVENT, THE PATIENT HAD PROLONGED HOSPITAL STAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310691 ENDOVIVE? JEJUNAL FEEDING TUBE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00566380 15716262

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DUODOPA