BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 3121604 · Received May 16, 2013

    Report

    Report Number
    2916596-2013-00616
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR IS ATTEMPTING TO ACQUIRE THE EXPLANTED PUMP FOR ANALYSIS. THE PT REMAINS ON LVAD SUPPORT WITH THE REPLACEMENT PUMP. NO FURTHER INFORMATION 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 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE (LVAD). APPROX 13 MONTHS POST-IMPLANT, PUMP THROMBOSIS WAS SUSPECTED DUE TO HEMOLYSIS PARAMETERS AND THE RESULTS OF A RAMP TEST CONDUCTED. SUBSEQUENTLY, A DECISION WAS MADE TO EXCHANGE THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216537 HEARTMATE II LVAS, EUROPE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104912 110596

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention