BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3961689 · Received June 17, 2014

    Report

    Report Number
    2916596-2014-01149
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    October 18, 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

    ACCORDING TO THE INFORMATION PROVIDED TO THE MANUFACTURER, THE EXPLANTED LVAD WAS DISPOSED OF BY THE HOSPITAL. 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. CAUSE OF EXCHANGE NOTED AS "PUMP THROMBOSIS". INFORMATION PROVIDED BY THE PERFUSIONIST INDICATED THAT THIS PATIENT WAS AT A SET SPEED OF 10, 2000 RPMS WITH POWER AT 7.5 WATTS, BUT HAD INTERMITTENT POWER ELEVATIONS UP TO 11.3 WATTS. LACTATE DEHYDROGENASE WAS AT 2100. SOME SMALL THROMBUS WAS SEEN AT THE TIME OF EXPLANT ON THE ROTOR AND IN THE PUMP STATORS. FOLLOWING THE PUMP EXCHANGE, THE PUMP WAS DISPOSED OF. NO INFORMATION ON PREEXISTING CONDITIONS OR INR IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355948 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 105903 107101

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention