BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3001613 · Received March 11, 2013

    Report

    Report Number
    2916596-2013-00264
    Event Type
    Injury
    Date Received
    March 11, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 12, 2013
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT CONTINUED ON LVAD SUPPORT WITH NO FURTHER ISSUES REPORTED. 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 (LVAD). THE VAD COORDINATOR REPORTED THAT THE PT EXPERIENCED A RED HEART ALARM. THE PT'S CAREGIVER NOTED THE FLOW DISPLAYED "---" ON THE DISPLAY MODULE. THE SPEED WAS NOT FLUCTUATING. PULSATILITY INDEX (PI) WAS NORMAL AND POWERS OF 1W. THE PT WAS ASYMPTOMATIC AND WAS SLEEPING BEFORE THE ALARMS WENT OFF. THE PT PRESENTED TO THE EMERGENCY ROOM FOR DEVICE INTERROGATION. THE CAREGIVER STATED THAT THE ALARMS CEASED WHEN SWITCHED TO BATTERIES BUT THAT ALARMS WOULD RETURN WHEN SWITCHED BACK TO THE POWER MODULE. THE ALARMS WERE UNABLE TO BE REPRODUCED. ACCORDING TO THE DOCTOR, AFTER PT UNDERGOING ECHOCARDIOGRAM (ECHO) AND 3D CAT SCAN, IT WAS DISCOVERED THE OUTFLOW GRAFT AT THE ANASTOMOSIS SITE HAS A STENOSIS OF 8MM. THE PT IS CURRENTLY ASYMPTOMATIC WITH NO ALARMS SINCE ADMITTED. THE PT WILL BE CLOSELY MONITORED FOR ANY CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101339 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911 107487

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other