BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3042036 · Received April 4, 2013

    Report

    Report Number
    2916596-2013-00330
    Event Type
    Death
    Date Received
    April 4, 2013
    Date of Event
    March 3, 2013
    Report Date
    March 6, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT EXPIRED AND NO AUTOPSY WAS PERFORMED. THE SYSTEM CONTROLLER WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. 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 A LEFT VENTRICULAR ASSIST DEVICE. IT WAS REPORTED THAT THE PT HAD A BROKEN BELT CLIP AND WAS ATTEMPTING TO EXCHANGE SYSTEM CONTROLLERS. THE PT WAS CONNECTED TO THE SYSTEM CONTROLLER AND WAS FOUND LYING FACE DOWN WITH BOTH SYSTEM CONTROLLERS OUT. THE PT WENT INTO CARDIAC ARREST AND HEART STOPPED. THE FINAL CAUSE OF DEATH WAS CARDIAC ARREST, BUT NO OFFICIAL AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138591 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103696 103571

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death