BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 3072365 · Received April 19, 2013

    Report

    Report Number
    2916596-2013-00367
    Event Type
    Injury
    Date Received
    April 19, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 22, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ON LVAD SUPPORT WITH THE REPLACEMENT PUMP WITH NO FURTHER ISSUES REPORTED. THE MFR IS ATTEMPTING TO ACQUIRE THE EXPLANTED PUMP FOR ANALYSIS. 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 PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. ACCORDING TO THE INFO RECEIVED, A CARDIO CT SCAN WAS PERFORMED FOLLOWING THE IMPLANTATION OF THE PUMP AND ONE WEEK LATER, POWER ELEVATIONS UP TO 14-16 WATTS WERE OBSERVED, FOLLOWED BY A DECREASE IN THE PULSATILITY INDEX (PI), AND THEN AN INCREASE IN THE PI. APPROX 1 MONTH POST-IMPLANT, THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR A PUMP EXCHANGED DUE TO SIGNS OF HEMOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169880 HEARTMATE II LVAS, EUROPE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106016 121050

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention