BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4122417 · Received September 18, 2014

    Report

    Report Number
    2916596-2014-01643
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    August 20, 2014
    Report Date
    August 20, 2014
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IN USE SUPPORTING THE PT. 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 ERYTHEMA WAS NOTED AT THE EXIT SITE OF THE DRIVELINE AND WAS 1/8 INCH IN WIDTH. THE DRIVELINE WAS CULTURED AND IT WAS FOUND TO BE STAPHYLOCOCCUS. THE PT IS BEING TREATED WITH DOXYCYCLINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579326 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 106015 139964

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention