BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 3121641 · Received May 9, 2013

    Report

    Report Number
    2916596-2013-00574
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 12, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ONGOING ON LVAD SUPPORT WITH NO FURTHER ISSUES. THE MFR IS ATTEMPTING TO ACQUIRE THE SUSPECT DEVICE FOR FURTHER EVALUATION. 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). THE MFR RECEIVED THE ATTACHED USER FACILITY REPORT (B)(4)FROM THE INTERMACS REGISTRY STATING THAT THE PT RECEIVED A RED HEART ALARM AND THE PUMP STOPPED. THE PT'S SPOUSE EXCHANGED THE SYSTEM CONTROLLER, AS PER INSTRUCTIONS IN THE INFO FOR USE (IFU), WITH NO RESIDUAL ISSUES. THE HOSPITAL PROVIDED THE PT WITH A REPLACEMENT SYSTEM CONTROLLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203648 HEARTMATE II SYSTEM CONTROLLER DSQ: LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103696 119318

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other