BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 3032889 · Received March 29, 2013

    Report

    Report Number
    2916596-2013-00359
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT SYSTEM CONTROLLER WAS RETURNED TO THE MFR AND IS CURRENTLY BING ANALYZED. 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR'S ADMINISTRATIVE ASSISTANT REPORTED THAT THE NURSE NOTED MULTIPLE RED HEART ALARMS AND PUMP DISCONNECTED/PUMP STOPPAGES WHEN THE SYSTEM CONTROLLER WAS EXCHANGED AS PER THE INSTRUCTIONS FOR USE (IFU) AND THE PT REMAINS ONGOING ON LVAD SUPPORT WITH NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129768 HEARTMATE II SYSTEM CONTROLLER DSQ: LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103696 102427

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Other