BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3131120 · Received May 23, 2013

    Report

    Report Number
    2916596-2013-00580
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 24, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ONGOING WITH THE IMPLANTED DEVICE. 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 PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR REPORTED THAT THE PATIENT WAS CONNECTED TO BATTERIES, BUT "THE PUMP FELT DIFFERENTLY". THE PATIENT EXPERIENCED A RED HEART ALARM. ADD'L INFO RECEIVED INDICATED THAT THE PUMP WAS STOPPED FOR ABOUT 25 MINUTES BEFORE THE PATIENT GOT TO THE HOSPITAL AND THE SYSTEM CONTROLLER WAS EXCHANGED. THE PUMP IMMEDIATELY RESTARTED WITH THE NEW SYSTEM CONTROLLER AND RAN WITHOUT ANY EVENTS OR ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228250 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 106932

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention