BEUDAMED
    FDA Adverse Event Death Summary report: N

    IROX

    MDR report key: 4891512 · Received July 6, 2015

    Report

    Report Number
    2124215-2015-08695
    Event Type
    Death
    Date Received
    July 6, 2015
    Date of Event
    June 22, 2015
    Report Date
    June 22, 2015
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    DTB
    PMA / PMN Number
    K890412
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS CURRENTLY AVAILABLE, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION APPROXIMATELY TWO MONTHS FOLLOWING AN UPGRADE TO A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) SYSTEM, THE CRT-P, RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS, ALONG WITH ANOTHER MANUFACTURER¿S RA AND LEFT VENTRICULAR (LV) LEADS WERE REMOVED DUE TO INFECTION AND EROSION. EXPOSURE OF THE GENERATOR AND LEADS WAS NOTED AND THERE WAS VEGETATION ON THE VALVES. THE PATIENT WAS PACEMAKER DEPENDENT, THEREFORE, FOR THE PROCEDURE, A PACING CATHETER WAS PLACED THROUGH THE GROIN, AND ANOTHER INTRACARDIAC LEAD IMPLANTED BUT CONNECTED EXTERNALLY TO A PACEMAKER NEAR THE NECK AREA. OVERALL, THE EXPLANT WAS COMPLICATED. THE FIRST LEAD TO BE EXPLANTED WAS ANOTHER COMPANY'S LV LEAD, AND IT WAS REMOVED WITHOUT ISSUE AS IT HAD ONLY BEEN IMPLANTED A FEW MONTHS. THE NEXT LEAD THAT WAS EXTRACTED WAS ANOTHER COMPANY'S RIGHT RA LEAD. WHEN THE LEAD WAS REMOVED THERE WAS A DROP IN THE PATIENT'S BLOOD PRESSURE. IT WAS THE PHYSICIAN'S IMPRESSION THAT AT SOME POINT, IN THE PAST, THE LEAD HAD PERFORATED THE HEART AND WAS EXTRA-CARDIAC. WITH ITS REMOVAL, PIN-SIZED HOLES WERE CREATED IN THE ATRIUM. A PERICARDIAL DRAIN WAS PLACED AND BLOOD WAS REMOVED VIA SYRINGES UNTIL THE DRAIN CLOTTED OFF AND NO FURTHER BLOOD COULD BE REMOVED; THE PATIENT WAS DOING POORLY AND CODED. NEITHER OF THE BACK UP PACING OPTIONS WERE ABLE TO OBTAIN CAPTURE AND THE PATIENT WENT BETWEEN ASYSTOLE AND VENTRICULAR FIBRILLATION (VF) FOR APPROXIMATELY TEN MINUTES UNTIL THE SURGEON ARRIVED. THE PATIENT'S CHEST WAS OPENED, THE PATIENT WAS STABILIZED, AND EPICARDIAL PACING WIRES WERE PLACED. THE SURGEON THEN ATTEMPTED TO REMOVE THE OTHER RA LEAD AND THE RV LEAD, BUT IN DOING SO THE SUPERIOR VENA CAVA TORE. THE SURGEON REPAIRED THE INJURY, HOWEVER, IT WAS NOTED THAT THE BLEEDING AND OOZING WOULD NOT QUIT. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT WITH AN UNFAVORABLE PROGNOSIS AND DIED IN THE EARLY MORNING HOURS THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437353 IROX IMPLANTABLE LEAD DTB GUIDANT ANGLETON/ST. PAUL 430-07

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death| H| L| R U128| 430-07| 4524| ADDR01| 4136| 294-03| 432-03| MISMATCH