BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3121589 · Received May 15, 2013

    Report

    Report Number
    2916596-2013-00615
    Event Type
    Death
    Date Received
    May 15, 2013
    Date of Event
    April 13, 2013
    Report Date
    April 16, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVALUATION. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED PT PASSED AWAY ON FRIDAY (B)(6) 2013. THE PT WAS READMITTED LAST WEEK WITH COMPLAINTS OF STRIDOR AND WAS DIAGNOSED WITH TRACHEAL STENOSIS. HE HAD A PROCEDURE BY ENT TO DO A TRACHEAL BALLOON ANGIOPLASTY. PT WAS DOING FINE AND AFTER WALKING AROUND THE UNIT IN ICU HE LAID ON THE BED AND HIS EYES ROLLED BACK AND HE ARRESTED. A FULL CODE WAS PERFORMED AND HE WAS IN ASYSTOLE. THEY OBSERVED THE PUMP TO BE RUNNING ON AUSCULTATION AND THERE WERE NOT ANY AUDIBLE OR VISUAL ALARMS. AFTER ALL MEDS GIVE, CHEST COMPRESSION WERE INITIATED AND THEY WERE UNABLE TO REVIVE THE PT AND HE EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214989 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAT ASSIST DEVICE DSQ THORATEC CORP. 103695 120909

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR