BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2431048 · Received January 26, 2012

    Report

    Report Number
    2916596-2012-00056
    Event Type
    Injury
    Date Received
    January 26, 2012
    Date of Event
    December 30, 2011
    Report Date
    December 30, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT UPON TRYING TO EXCHANGE THE SYSTEM CONTROLLER THE HOSPITAL STAFF WAS UNABLE TO DEPRESS THE RELEASE TAB ON THE SYSTEM CONTROLLER. IT WAS NOTED THAT THE AREA WAS QUITE DIRTY. PER ADD'L INFO RECEIVED, THE PERCUTANEOUS LEAD WAS LATER REMOVED FROM THE SYSTEM CONTROLLER AND THE CONTROLLER WAS EXCHANGED.

    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