BEUDAMED
    FDA Adverse Event Death Summary report: N

    BOSTON SCIENTIFIC

    MDR report key: 805381 · Received November 2, 2006

    Report

    Report Number
    805381
    Event Type
    Death
    Date Received
    November 2, 2006
    Date of Event
    July 23, 2006
    Report Date
    November 2, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORP
    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

    PATIENT ADMITTED IN 2006, AFTER BEING HIT BY A CAR WHILE WALKING AS A PEDESTRIAN. SUSTAINED A FRACTURED LEFT TIBIA, REPAIRED WITH A PLATE. PT UNDERWENT ETOH WITHDRAWAL, AND DURING THAT TIME ALSO DEVELOPED CELLULITIS OF HIS LEFT LOWER EXTREMITY. TAKEN TO THE OR FOR PLACEMENT OF ANTIBIOTIC BEADS. LATER RETURNED TO OR FOR SEVERAL I&D'S WITH A WOUND VAC EVENTUALLY PLACED. DURING HIS LONG STAY, HE ALSO DEVELOPED ACUTE RENAL FAILURE AND RESPIRATORY DISTRESS WITH FAILURE. HE WAS PLACED ON A VENT AND EVENTUALLY RECEIVED A TRACHEOSTOMY. A LEFT UPPER LOBE LUNG MASS WAS DISCOVERED FIRST IN 2005 AND PT HAD REFUSED ANY WORKUP, NOW CT SHOWS MILD INCREASE IN SIZE, PT CONTINUES TO REFUSE WORKUP. DUE TO PT'S CONTINUED VENT AND NEED FOR NUTRITION, IT WAS DECIDED TO PLACE A PEG A MONTH EARLIER. FIVE DAYS LATER, HE WAS EMERGENTLY TAKEN TO THE OR WITH INTRA-ABDOMINAL SEPSIS FOR AN EXPLORATORY LAPAROTOMY, GASTROSTOMY REPAIR AND AN OPEN GASTROSTOMY TUBE REPLACEMENT. FINDINGS: APPROXIMATELY 3 LITERS OF ABDOMINAL ASCITES, STAINED WITH BILE. THE PEG TUBE HAD ERODED THROUGH THE ANTERIOR STOMACH AND THE BUTTON WAS OUTSIDE THE STOMACH. CRITICALLY ILL WITH MULTISYSTEM ORGAN FAILURE, GANGRENOUS LLE. COMFORT CARES INITIATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death| H| L| R