BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2843490 · Received November 19, 2012

    Report

    Report Number
    2916596-2012-01139
    Event Type
    Injury
    Date Received
    November 19, 2012
    Date of Event
    September 14, 2012
    Report Date
    October 25, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 THE PT WAS DIAGNOSED WITH A DRIVELINE INFECTION, AND THE DRIVELINE SITE HAD ¿PEA GREEN COLORED¿ DRAINAGE. ORAL ANTIBIOTICS WERE ADMINISTERED AND THE SITE DRAINAGE IMPROVED. THE PT REMAINS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 114711

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention