BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4142716 · Received October 2, 2014

    Report

    Report Number
    2916596-2014-01739
    Event Type
    Injury
    Date Received
    October 2, 2014
    Date of Event
    August 28, 2014
    Report Date
    September 3, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    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 BIO MED ENGINEER THAT THE PT "IS BELIEVED TO HAVE SELF-DISCONNECTED HIS PUMP ON THURSDAY (B)(6) 2014 OR FRIDAY (B)(6) 2014." THE PT IS NO LONGER ONGOING. THE PUMP HAS BEEN STOPPED AND IS CONSIDERED "RECIPIENT-INDUCED EXPLANTED." THE PT IS STILL ALIVE. THE DATA LOG INFO REVEALED THAT THE FIRST DRIVELINE DISCONNECT ALARM OCCURRED ON (B)(6) 2014. THE PT HAD GONE INTO THE EMERGENCY ROOM MORE THAN 24 HOURS AFTER DISCONNECTING THE DRIVELINE. IT WAS NOT PHYSICALLY SAFE TO RESTART THE PUMP AND THE PT SEEMED TO BE HEMODYNAMICALLY STABLE. THE HOSP IS LOOKING FOR ANY REGURGE THROUGH THE PUMP. THE HOSP LOOKED FOR ANY REGURGITATION THROUGH THE PUMP. THERE ARE NO CURRENT PLANS TO PHYSICALLY EXPLANT THE PUMP OR REPLACE IT BASED ON THE PT'S "RECOVERY" STATUS OF HEART FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614297 HEARTMATE II LVAS DSQ THORATEC CORP. 106015 128886

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention