BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 3934265 · Received June 27, 2014

    Report

    Report Number
    2916596-2014-00935
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 28, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE EXPLANTED PUMP 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 (LVAD). APPROXIMATELY 7 MONTHS POST-IMPLANT, IT WAS REPORTED THAT THE PATIENT WAS ADMITTED INTO THE HOSPITAL DUE TO ELEVATED LDH LEVELS AND AN INCREASE IN PL LEVELS. THE PATIENT REPORTED FEELING FINE AND HAD NO SYMPTOMS. AN ECHOCARDIOGRAM WAS PERFORMED AND INDICATED THAT THE AORTIC VALVE OPENED WITH EVERY BEAT. THE HOSPITAL STARTED THE PATIENT ON IV HEPARIN WHICH DECREASED THE PI AND LDH LEVELS; HOWEVER, THE FOLLOWING DAY BOTH LEVELS INCREASED AGAIN. THE PATIENT WAS PUT ON THE URGENT TRANSPLANT LIST AND THE PATIENT WAS SUCCESSFULLY TRANSPLANTED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377342 HEARTMATE II LVAS, EUROPE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106016 127761

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention