BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2861327 · Received December 5, 2012

    Report

    Report Number
    2916596-2012-01182
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 8, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 WAS GOING TO HAVE THE PUMP EXCHANGED DUE TO PUMP FLOW PROBLEMS. THE PT WAS SYMPTOMATIC WITH SHORTNESS OF BREATH, FATIGUE, AND RIGHT HEART DYSFUNCTION. A HEART BECAME AVAILABLE BEFORE THE PUMP WAS EXCHANGED AND THE PT UNDERWENT A HEART TRANSPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 112481

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening