BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 1971505 · Received January 21, 2011

    Report

    Report Number
    2916596-2011-00029
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    December 29, 2010
    Report Date
    December 29, 2010
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVALUATION. 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). IT WAS REPORTED BY THE VAD COORDINATOR THAT PATIENT LOG FILES WERE SENT TO THE MANUFACTURER FOR REVIEW AND CONFIRMED SEVERAL POWER SPIKES AND A STEADY INCREASE IN POWER AND FLOW READINGS. IN ADDITION, A FEW WEEKS AGO, A LEFT VENTRICULAR ANGIOGRAM WAS DONE WHICH REVEALED SOME POTENTIAL OBSTRUCTION. THE PATIENT WAS ALSO EXPERIENCING SOME SHORTNESS OF BREATH. THE PATIENT'S CASE WAS DISCUSSED WITH THE MANUFACTURER'S CLINICAL REPRESENTATIVE AND IT WAS AGREED THAT THERE IS MOST LIKELY THROMBUS IN THE PUMP. APPROXIMATELY ONE WEEK LATER, A DECISION WAS MADE TO EXCHANGE THE LVAD PUMP WITH ANOTHER LVAD PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention