BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2503206 · Received March 20, 2012

    Report

    Report Number
    2916596-2012-00239
    Event Type
    Malfunction
    Date Received
    March 20, 2012
    Date of Event
    February 21, 2012
    Report Date
    February 21, 2012
    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 PT REMAINS ON GOING WITH THE IMPLANTED DEVICE AND NO FURTHER ISSUES HAVE BEEN 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). IT WAS REPORTED BY THE VAD COORD THAT A ROUTINE X-RAY REVIEW FOR PT TRANSPLANT EVAL SHOWED MIGRATION OF THE BEND RELIEF. THE PT WAS NOT SYMPTOMATIC AND NO INTERVENTION WAS PERFORMED TO REATTACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 104652

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other