BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2930349 · Received January 22, 2013

    Report

    Report Number
    2916596-2013-00087
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 24, 2012
    Report Date
    December 24, 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 PATIENT REMAINS ONGOING WITH THE IMPLANTED DEVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    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 WAS PRESENTED TO THE EMERGENCY DEPARTMENT WITH INCREASING HEART FAILURE SYMPTOMS AND AN ELEVATED LACTATE DEHYDROGENASE (LDH). AN ECHO CARDIOGRAM (ECHO) WAS PERFORMED WHICH SHOWED A DISTENDED LEFT VENTRICULAR, WITH NO SIZE CHANGE FROM 8600 TO 9800 AND CR INCREASING AS WELL. PATIENT IS ON A HEPARIN DRIP AND DOBUTAMINE. ADDITIONAL INFORMATION RECEIVED ADVISED THAT THE PATIENT WAS TRANSFERRED TO THE IMPLANTING CENTER. THE PATIENT HAD SIGNIFICANT RIGHT SIDED FAILURE AND IT SUSPECTED THAT THE LVAD PUMP IS NOT OPERATING AS EXPECTED. THEY ARE CONSIDERING TRANSFERRING THE PATIENT ONTO ANOTHER CENTER TO IMPLANT ANOTHER DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29565 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 115175

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention