BEUDAMED
    FDA Adverse Event Death Summary report: N

    HANCOCK II

    MDR report key: 1245992 · Received November 11, 2008

    Report

    Report Number
    1245992
    Event Type
    Death
    Date Received
    November 11, 2008
    Date of Event
    October 31, 2008
    Report Date
    November 11, 2008
    Manufacturer
    MEDTRONIC
    Product Code
    LWR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    THIS IS THE SECOND OF TWO PATIENTS EXPERIENCING SIMILAR POTENTIAL DEVICE MALFUNCTION. THIS IS AN AMERICAN SOCIETY OF ANESTHESIOLOGISTS (ASA) SCORE 3 PATIENT ON BY-PASS WITH HEART BEATING THROUGHOUT PROCEDURE; ON BY-PASS 85 MINUTES. DURING PROCEDURE THERE WERE INDICES OF NORMAL PERFUSION, I.E. CEREBRAL OXYGEN SATURATION, VENOUS OXYGEN SATURATION, PERIPHERAL OXYGEN SATURATION, BLOOD PRESSURE (BP), AND BYPASS FLOW RATE. AT END OF CASE, THERE WAS AN UNEXPECTEDLY ELEVATED LACTATE LEVEL, SPLOTCHY, PURPURIC RASH, MILD MULTI-ORGAN DYSFUNCTION (LIVER AND KIDNEY), NORMAL HEART FUNCTION AND OUTPUT, CREATINE PHOSPHOKINASE (CPK) LEVEL >3000, AND POSSIBLE BOWEL ISCHEMIA. THE PATIENT'S LAB VALUES RESOLVED WITHIN 12 HOURS, BUT PATIENT DID NOT WAKE UP APPROPRIATELY. MRI DONE, INDICATING BRAIN DEATH. LIFE SUPPORT WITHDRAWN; AUTOPSY RESULTS PENDING. MEDTRONIC NOTIFIED, FDA NOTFIED, OUR INVESTIGATION IS ON-GOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HANCOCK II IMPLANT, VALVE, HEART LWR MEDTRONIC 105 *

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Death