BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2463585 · Received February 16, 2012

    Report

    Report Number
    2916596-2012-00147
    Event Type
    Injury
    Date Received
    February 16, 2012
    Date of Event
    January 17, 2012
    Report Date
    January 18, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT AFTER 4 MONTHS OF SUPPORT, THE PT WAS EXPERIENCING CONTINUOUS RED HEART ALARMS. NO SIGNIFICANT CHANGES IN PULSATIVE INDEX (PI) WERE NOTED. THE ATRIAL VALVE WAS REPORTEDLY OPENING AT THE PUMP SPEED OF 9400 RPM. THE DEVICE WAS SUCCESSFULLY EXCHANGED WITH ANOTHER LVAD AND THE PT REMAINS ONGOING WITHOUT ANY FURTHER ISSUES REPORTED. ADD'L INFO PROVIDED TO THE MFR INDICATED THAT THE PT HAD A HISTORY OF LV THROMBUS BUT NO KNOWN DOCUMENTATION OF INFECTION OR FEVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 107484

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention