BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2092590 · Received May 4, 2011

    Report

    Report Number
    2916596-2011-00172
    Event Type
    Injury
    Date Received
    May 4, 2011
    Date of Event
    March 18, 2011
    Report Date
    April 4, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVAL. NO FURTHER INFO 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 LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT DECOMPENSATED AND REQUIRED CHEST COMPRESSIONS. IT WAS NOTED THAT AFTER CHEST COMPRESSIONS, THE PUMP PARAMETERS WERE DIFFERENT THAN WHAT THEY WERE PRIOR TO THE CHEST COMPRESSIONS. THE PT WAS SUBSEQUENTLY DIAGNOSED WITH THROMBUS IN THE PUMP, AND THE HOSP STAFF DECIDED TO EXCHANGE THE PUMP. THE LVAD WAS EXCHANGED WITH A NEW LVAD, AND THE PT REMAINS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 102430

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention