BEUDAMED
    FDA Adverse Event Death Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 778916 · Received November 2, 2006

    Report

    Report Number
    778916
    Event Type
    Death
    Date Received
    November 2, 2006
    Date of Event
    August 15, 2006
    Report Date
    November 2, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PEG PLACED IN 2006 FOR CHRONIC MALNUTRITION AND DISCHARGED BACK TO NURSING HOME THE NEXT DAY. AFTER RETURNING TO NURSING HOME PATIENT EXPERIENCED SEVERAL FALLS. READMIT FOUR DAYS LATER WITH HYPOTENSION AND PERITONITIS. TAKEN EMERGENTLY TO THE OPERATING ROOM FOR AN EXPLORATORY LAPAROTOMY AND STAMM GASTROSTOMY WITH A MIC PLACED. THE PERCUTANEOUS ENDOSCOPIC GASTROSTOMY (PEG) TUBE BUMPER HAD BEEN PULLED OUT OF THE STOMACH AND THERE WAS FREE CONTAMINATION OF THE ABDOMEN. HE WAS TREATED WITH BROAD-SPECTRUM ANTIBIOTICS, IMPROVED WITH THIS ANTIBIOTIC REGIMEN. PATIENT EXPERIENCED FEVER SPIKES TOWARD THE END OF HIS HOSPITALIZATION, HOWEVER, INITIAL PANCULTURE, CHEST X-RAY AND ABDOMINAL CT DID NOT SHOW ANY SOURCE OF INFECTION. REMOVED PATIENT'S PALATE ORTHOTIC AND FOUND A LARGE AMOUNT OF PURULENT DRAINAGE FROM NASAL CAVITY. PATIENT STARTED ON LEVOFLOXACIN AND IRRIGATIONS OF THE NASAL CAVITY. PATIENT DC'D TO NURSING HOME THIRTEEN DAYS AFTER ADMISSION. PATIENT READMITTED FOUR DAYS LATER WITH RESPIRATORY DISTRESS AND FEVER. PRESENTS WITH PNEUMONIA, (REPEAT CXR SHOWS A TOTALLY COLLAPSED LEFT LUNG), AND WITH HIS MANY RECENT ACUTE PROBLEMS, INCLUDING ADVANCED SQUAMOUS CELL CANCER OF THE PALATE HE WOULD NEED VERY AGGRESSIVE INTERVENTION, WHICH IS NOT HIS WISHES. COMFORT CARES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC STANDARD PEG KIT-PUSH METHOD KNT BOSTON SCIENTIFIC CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death| H| L| R