BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 3093936 · Received April 30, 2013

    Report

    Report Number
    2916596-2013-00496
    Event Type
    Death
    Date Received
    April 30, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 1, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR EVAL. ALL INTERNAL WIRES WERE MEASURED DURING ANALYSIS AND THERE WAS NO ISSUES OBSERVED. THE SYSTEM CONTROLLER WAS FUNCTIONALLY TESTED UNDER VARIOUS LOADED CONDITIONS USING A MOCK CIRCULATORY LOOP AND WAS FOUND TO OPERATE AS INTENDED. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MFG OR QA SPECIFICATIONS. NO FURTHER INFO IS AVAILABLE. THE MFR IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT THE PT SUDDENLY EXPIRED. THE PT DIDN'T LOOK WELL FOR SEVERAL WEEKS LEADING UP TO HIS DEATH. THE PT'S RECENT COMPUTED TOMOGRAPHY SCAN SHOWED GROWING METASTASES FROM HIS PROSTATE CANCER. THE PT BECAME ACUTELY UNRESPONSIVE AND EMERGENCY MEDICAL SERVICES (EMS) WERE CALLED BUT COULDN'T BRING HIM BACK. THE PT'S WIFE STATED THAT THERE WERE NO VAD ALARMS AND THE PT'S IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) DID NOT FIRE WHICH MADE THE HOSP SUSPECT THE PT WENT ASYSTOLE. NO AUTOPSY WAS PERFORMED AND THE PUMP WAS NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187521 HEARTMATE II SYSTEM CONTROLLER DSQ: LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103696 107796

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death