BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3161747 · Received June 6, 2013

    Report

    Report Number
    2916596-2013-00712
    Event Type
    Death
    Date Received
    June 6, 2013
    Date of Event
    March 31, 2013
    Report Date
    May 8, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WILL NOT BE RETURNING TO THE MANUFACTURER FOR EVALUATION, AS THE PUMP WAS NOT EXPLANTED FROM THE PATIENT. 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). THE VAD COORDINATOR REPORTED THAT THE PATIENT DIED AT A NURSING HOME. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE PATIENT'S DEATH AND NO AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251160 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 118910

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death