BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3170007 · Received June 7, 2013

    Report

    Report Number
    2916596-2013-00708
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    April 12, 2013
    Report Date
    May 10, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORT # (B)(4) WAS RECEIVED FROM THE (B)(6) REGISTRY. THE PT CONTINUES ON LVAD SUPPORT. 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). AN (B)(6) REGISTRY REPORT WAS RECEIVED WHICH INDICATED THAT THE PT WAS ADMITTED FOR PUMP THROMBUS. THE PT HAD INCREASED LACTATE DEHYDROGENASE (LDH), ABNORMAL PUMP SOUNDS, AND ABNORMAL ECHOCARDIOGRAM (ECHO). THE PUMPS' SPEED WAS INCREASED TO COMPENSATE FOR THE CLOT AND WILL LIST THE PT FOR TRANSPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253607 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 120268

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention