BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 2800921 · Received October 18, 2012

    Report

    Report Number
    2916596-2012-01007
    Event Type
    Injury
    Date Received
    October 18, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 24, 2012
    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 PT REMAINS ON LVAD SUPPORT WITH THE REPLACEMENT PUMP AND NO FURTHER ISSUES HAVE BEEN REPORTED. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS AND IS CURRENTLY IN PROCESS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. APPROXIMATELY 6 DAYS POST-IMPLANT, AN INCREASE IN PUMP POWER WAS REPORTED AN A REDUCTION IN FLOW WAS OBSERVED. THROMBOLYSIS WAS SUSPECTED A DECISION WAS MADE TO EXCHANGE THE PUMP. ACCORDING TO THE INFORMATION PROVIDED, THE CLINIC SUSPECTS THAT THE PT MAY HAVE DEVELOPED HEPARIN INDUCED THROMBOCYTOPAENIA (HIT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS, EUROPE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP 104912 111620

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention