BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2810005 · Received October 23, 2012

    Report

    Report Number
    2916596-2012-01014
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    July 3, 2012
    Report Date
    September 25, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT CONTINUES ON LVAD SUPPORT WITH NO FURTHER ISSUE REPORTED. 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). THE VAD COORDINATOR REPORTED THAT, AFTER APPROX 1 1/2 MONTH OF SUPPORT, THE PT PRESENTED WITH ELEVATED HAPTOGLOBIN AND ELEVATED LACTATE DEHYDROGENASE (LDH). THE PT WAS "MAXIMIZED ON ANTICOAGULATION" FOR AN INTERNATIONAL NORMALIZED RATIO (INR) CLOSER TO 2.5 AND THE SYMPTOMS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 114021

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention