BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3760785 · Received April 7, 2014

    Report

    Report Number
    2916596-2014-00469
    Event Type
    Injury
    Date Received
    April 7, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 12, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LVAD WAS RETURNED TO THE MFR FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. 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 WIT A LEFT VENTRICULAR ASSIST DEVICE. THE HOSPITAL REPORTED THAT THE PT HAD LOW FLOW RED HEART ALARMS AT HOME. THE SYSTEM CONTROLLER WAS EXCHANGED, BUT THE PT CONTINUED TO HAVE LOW FLOW ALARMS. THE PT ALSO HAD ONE PUMP STOP. THE PT WAS READMITTED TO THE HOSPITAL. EVENT LOGS CONFIRMED THE LOW FLOW EVENTS AND PUMP STOPPAGE. THE PT UNDERWENT A PUMP EXCHANGE ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205717 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 119467

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention