BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOVIVE¿ JEJUNAL FEEDING TUBE

    MDR report key: 2887491 · Received December 27, 2012

    Report

    Report Number
    3005099803-2012-06323
    Event Type
    Injury
    Date Received
    December 27, 2012
    Report Date
    December 3, 2012
    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 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 ENDOVIVE TWO-PORT THROUGH THE PEG JEJUNAL FEEDING TUBE (J-TUBE) WAS BEING USED FOR THE PURPOSE OF ADMINISTERING MEDICATION FOR THE ADVANCE STAGE OF PARKINSON'S DISEASE. THE DEVICE WAS PLACED ON (B)(6) 2012 ACCORDING TO THE COMPLAINANT, THE LOOP ON J-TUBE WAS DESCENDING IN THE DUODENUM. THE DEVICE WAS REMOVED ON (B)(6) 2012. 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 ENDOVIVE TWO-PORT THROUGH THE PEG JEJUNAL FEEDING TUBE (J-TUBE) WAS BEING USED FOR THE PURPOSE OF ADMINISTERING MEDICATION FOR THE ADVANCE STAGE OF PARKINSON'S DISEASE. THE DEVICE WAS PLACED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE LOOP ON J-TUBE WAS DESCENDING IN THE DUODENUM. THE DEVICE WAS REMOVED ON (B)(6) 2012. 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) 2013: IT COULD NOT BE CONFIRMED IF THE J-TUBE HAD MIGRATED OR DISLODGED FROM WHERE IT WAS ORIGINALLY PLACED. THE PHYSICIAN REPORTED THE J-TUBE WAS KINKING IN THE DUODENUM. THE PHYSICIAN REMOVED THE KINK UNDER ENDOSCOPIC VISION UNRAVELS WITH FORCEPS, EXTRACTS THE J-TUBE AND PLACES A NEW ENDOVIVE TWO-PORT THROUGH THE PEG JEJUNAL FEEDING TUBE (J-TUBE). PATIENT¿S CONDITION WAS REPORTED TO BE GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOVIVE¿ JEJUNAL FEEDING TUBE TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER M00566380 14226969

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DUODOPA| ROPINIROL 4MG/DIE