BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3111364 · Received May 9, 2013

    Report

    Report Number
    2916596-2013-00536
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    March 27, 2013
    Report Date
    April 10, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS 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 HAD LOW FLOW AND LOW SPEED ALARMS, WHICH THE BEDSIDE NURSE COULD NOT SILENCE. THE PATIENT'S CHEST WAS OPENED AT THE BEDSIDE FOR CARDIAC TAMPONADE AND THE SYSTEM CONTROLLER WAS EXCHANGED. THE PATIENT REMAINS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202533 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103696

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention