BEUDAMED
    FDA Adverse Event Death Summary report: N

    ITREL 3

    MDR report key: 1190232 · Received October 6, 2008

    Report

    Report Number
    3004209178-2008-06363
    Event Type
    Death
    Date Received
    October 6, 2008
    Date of Event
    January 1, 2001
    Report Date
    January 1, 2001
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED FOLLOWING AN INTERNAL AUDIT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FIVE DAYS FOLLOWING IMPLANT OF THE DEVICE THE PT DEVELOPED HYPOXIA WITH RAPIDLY DECREASING OXYGEN SATURATIONS. HER RHYTHM WAS PEA AND SHE WAS TREATED WITH FLUIDS, ATROPINE, AND EPINEPHRINE, FOLLOWED BY TISSUE PLASMINOGEN ACTIVATOR (T-PA). THE PT REGAINED A PULSE AND BLOOD PRESSURE. A PERFUSION SCAN WAS PERFORMED WHICH SHOWED NO PERFUSION TO THE RIGHT LUNG. SHE THEN UNDERWENT MECHANICAL THROMBOLYSIS AND REPEATED T-PA. SOME RESIDUAL CLOT REMAINED IN THE RIGHT PULMONARY ARTERY. TWO DAYS LATER THE PT REMAINED CRITICALLY ILL. SHE WAS NON-RESPONSIVE TO VERBAL AND TACTILE STIMULI. NEUROLOGY FELT THE PT MOST LIKELY HAD ANOXIC ENCEPHALOPATHY. IN THE FOLLOWING DAYS HER MENTAL STATUS REMAINED UNCHANGED. SHE WAS PLACED ON MORPHINE AND VERSED DRIPS FOR COMFORT AND REMOVED FROM THE VENTILATOR. SHE SUBSEQUENTLY EXPIRED. AN AUTOPSY WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 LNQ MEDTRONIC PUERTO RICO OPERATIONS CO. 7425G NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death IMPLANTED| LEAD MODEL 4300 LOT# PBP005117K| EXPLANTED| IMPLANTED| EXPLANTED| LEAD MODEL 4300 LOT # PBP005112K