BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE CAP

    MDR report key: 2071753 · Received April 28, 2011

    Report

    Report Number
    3005099803-2011-01480
    Event Type
    Injury
    Date Received
    April 28, 2011
    Report Date
    April 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    KNT
    PMA / PMN Number
    K081739
    Adverse Event
    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. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, AS IT IS IMPLANTED; 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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS THAT OCCURRED DURING THE SAME PROCEDURE. REFER TO MANUFACTURER REPORT # 3005099803-2011-01481 FOR THE OTHER ASSOCIATED DEVICE INFORMATION. IT WAS REPORTED TO BOSTON SCIENTIFIC THAT A TWO PORT THROUGH THE PEG JEJUNAL FEEDING TUBE (J-TUBE) WAS BEING USED FOR THE PURPOSE OF ADMINISTERING MEDICATION FOR THE ADVANCED STAGE OF PARKINSON'S DISEASE. ACCORDING TO THE COMPLAINANT, FOR APPROXIMATELY THREE WEEKS THE PATIENT HAS PRESENTED WITH A SLIGHT REDNESS AROUND THE STOMA AND PAIN IN THE STOMA. A CULTIVATION WAS TAKEN ON (B)(6), 2011. THERE IS NO DAMAGE TO THE J-TUBE AND THIS DEVICE REMAINS IMPLANTED. 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
    1 ENDOVIVE TWO-PORT TTP JEJUNAL FEEDING TUBE CAP TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT BOSTON SCIENTIFIC - SPENCER UNK443

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DUODOPA