BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2861608 · Received November 28, 2012

    Report

    Report Number
    2916596-2012-01129
    Event Type
    Malfunction
    Date Received
    November 28, 2012
    Date of Event
    September 12, 2012
    Report Date
    October 31, 2012
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVAL. 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 SYSTEM CONTROLLER STOPPED WORKING AND THE PT WAS BRADYCARDIC AND "DOWN AND OUT FOR A MIN". THE SYSTEM CONTROLLER WAS REPLACED AND THE ISSUE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER DSQ: SYSTEM CONTROLLER DSQ THORATEC CORPORATION 103696 87112

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention