BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3834446 · Received May 6, 2014

    Report

    Report Number
    2916596-2014-00712
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 7, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO 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 (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT EXPERIENCED ELEVATED LACTATE DEHYDROGENASE UP TO 3000 AND DECREASE PLATELETS. THE PT WAS ADMITTED AND UNDERWENT A PUMP EXCHANGE FROM ONE LVAD TO ANOTHER LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271039 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 136667

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention