BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS EUROPE

    MDR report key: 2440409 · Received January 31, 2012

    Report

    Report Number
    2916596-2012-00117
    Event Type
    Injury
    Date Received
    January 31, 2012
    Date of Event
    January 5, 2012
    Report Date
    January 5, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    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 MANUFACTURER IS ATTEMPTING TO ACQUIRE THE EXPLANTED DEVICE FOR ANALYSIS. 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. APPROXIMATELY 1 MONTH POST-IMPLANT, THE PATIENT RECEIVED RED HEART ALARMS AND AN INCREASE IN POWER WAS NOTED. A RAMP STUDY REVEALED NO CHANGE IN LEFT VENTRICLE (LV) DIMENSION WITH AN INCREASE OF SPEED FROM 8,000 TO 12,000 RPM. A LOW PL VALUE WAS NOTED AND THE AORTIC VALVE WAS OPENING WITH EVERY BEAT. A DECISION WAS MADE TO EXCHANGE THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS EUROPE VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103693

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention