BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEART II LVAS

    MDR report key: 4122425 · Received September 18, 2014

    Report

    Report Number
    2916596-2014-01648
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    January 20, 2014
    Report Date
    August 20, 2014
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION AS IT REMAINS IN USE SUPPORTING THE PATIENT. NO FURTHER ISSUES RELATED TO THE INFECTION HAVE BEEN REPORTED. A DIRECT CORRELATION BETWEEN THE REPORTED INFECTION AND THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET ALL APPLICABLE SPECIFICATIONS UPON PRODUCT RELEASE. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT HAS HAD CHRONIC DRIVELINE INFECTIONS FOR THE LAST 6 TO 8 MONTHS. THE PATIENT IS CURRENTLY BEING TREATED WITH MOXIFLOXACIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579256 HEART II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911 104911

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention