BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 1870925 · Received October 7, 2010

    Report

    Report Number
    2916596-2010-00251
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    September 17, 2010
    Report Date
    September 17, 2010
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVALUATION. 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. THE VAD COORDINATOR REPORTED THAT THE PT'S SYSTEM CONTROLLER ALARMED AUDIBLY, BUT WITHOUT VISUAL ALARMS. THE PT STARTED TO FEEL BAD AND CALLED EMERGENCY RESCUE SERVICES. THE SYSTEM CONTROLLER WAS EXCHANGED AND THE ISSUE WAS RESOLVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention