BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3911649 · Received May 28, 2014

    Report

    Report Number
    2916596-2014-00847
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    April 12, 2014
    Report Date
    April 28, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IN USE SUPPORTING THE PT. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2010. ON (B)(6) 2014, THE PT WAS TRANSFERRED TO THE IMPLANTING CENTER FROM ANOTHER HOSPITAL WITH SEPTIC SHOCK AND RESPIRATORY DISTRESS AND WAS INTUBATED AND ON VASOPRESSORS. IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT IS BACTEREMIC WITH E COLI AND CORYNEBACTERIUM STRIATUM, AND ALSO HAS A PUMP DRIVELINE INFECTION WITH CORYNEBACTERIUM STRIATUM. ON (B)(6) 2014, A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED WHICH SHOWED NO EVIDENCE OF VEGETATIONS. THE PT WAS TREATED WITH IV ANTIBIOTICS WHICH WERE ADJUSTED THROUGHOUT HIS HOSPITALIZATION. ON (B)(6) 2014, THE PT WAS EXTUBATED AND THE VASOPRESSORS WEANED OFF. ON (B)(6) 2014, THE PT WAS HEMODYNAMICALLY STABLE AND WAS DISCHARGED TO HOME WITH IV ANTIBIOTICS ADMINISTRATION AND CONTINUED ROUTINE HEMODIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314211 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 91845

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention