BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2092656 · Received May 10, 2011

    Report

    Report Number
    2916596-2011-00186
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 11, 2011
    Report Date
    April 12, 2011
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVALUATION. NO FURTHER INFO 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT HAD BEEN ADMITTED INTO THE LOCAL HOSPITAL FOR APPROX ONE WEEK TO BE MANAGED FOR KIDNEY ISSUES. THE PT WAS EXPERIENCING CHANGES IN FLOWS AND POWER SPIKES DURING THIS TIME. THE PT ALSO HAD NOTED HEMATURIA AND A QUESTIONABLE RIGHT VENTRICULAR. IT WAS DECIDED TO MOVE THE PT TO THE LVAD IMPLANT CENTER WHERE A DECISION WAS MADE TO EXCHANGE THE LVAD WITH ANOTHER LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 103695 88424

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention