BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3961699 · Received June 17, 2014

    Report

    Report Number
    2916596-2014-01143
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    November 7, 2013
    Report Date
    June 22, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER WAS ADVISED THAT THE DEVICE WILL NOT BE RETURNING FOR EVALUATION AS IT WAS DISPOSED OF AT THE TIME OF EXPLANT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). INFORMATION WAS PROVIDED TO THE MANUFACTURER THROUGH THEIR DEVICE TRACKING SYSTEM INDICATING THAT A PUMP EXCHANGE TOOK PLACE ON (B)(6) 2013. THE CAUSE OF EXCHANGE WAS NOTED AS "THROMBUS". INFORMATION PROVIDED BY THE PERFUSIONIST INDICATED THAT PUMP POWER VARIABLE BUT NO OBVIOUS SIGNIFICANT ELEVATIONS. SPEED 9400 RPM, POWER AVERAGE AROUND 6. ELEVATIONS UP TO 10.3 AT TIME. LDH 2000. PUMP WAS EXCHANGED. THROMBUS SEEN ON INFLOW BEARING AND ROTOR, OUTFLOW STATOR AND BEARING. PUMP NOT RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355974 HEARTMATE II LVAS DSQ: LEFT VENTICULAR ASSIST DEVICE DSQ THORATEC CORP. 1355 63499

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention