BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2800803 · Received October 17, 2012

    Report

    Report Number
    2916596-2012-01002
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    September 21, 2012
    Report Date
    September 21, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. NO FURTHER INFORMATION 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 PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT REMAINS IN THE HOSPITAL SINCE THE PUMP WAS IMPLANTED AND HAD EPITAXIS. THE PATIENT'S NOSE WAS PACKED BY AN EARS/NOSE/THROAT (ENT) PHYSICIAN. IT WAS ALSO REPORTED THAT THE PATIENT WAS HAVING ISSUES WITH RIGHT HEART FAILURE AND IS CURRENTLY ON DOBUTAMINE AND MILRINONE DRIP. THE PATIENT REMAINS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 117497

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention