BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 3030265 · Received March 28, 2013

    Report

    Report Number
    2916596-2013-00333
    Event Type
    Injury
    Date Received
    March 28, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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). THE MFR WAS ADVISED THAT A PUMP EXCHANGE FROM ONE LVAD TO ANOTHER LVAD TOOK PLACE. ADDITIONAL INFO WAS RECEIVED BY THE MFR THE FOLLOWING DAY ADVISING THAT THE EXCHANGE TOOK PLACE BECAUSE OF SUSPICIONS OF THROMBUS DUE TO HIGH LACTATE DEHYDROGENASE (LDH) LEVELS AND DARK COLORED URINE. THE PT HAD BEEN ON INTEGRILLIN GTT WITH TEMPORARY IMPROVEMENT, BUT ONCE OFF THE GTT, THE SYMPTOMS RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127513 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 98720

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention