BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2800382 · Received October 18, 2012

    Report

    Report Number
    2916596-2012-01009
    Event Type
    Death
    Date Received
    October 18, 2012
    Date of Event
    September 8, 2011
    Report Date
    September 21, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INFO PROVIDED TO THE MFR, THE EXPLANTED LVAD WAS DISPOSED OF BY THE HOSPITAL. 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT THE PT EXPIRED THREE WEEKS POST IMPLANTATION OF THE LVAD. THE PT HAD HYPERTROPHIC CARDIOMYOPATHY AND FAILED TO PROGRESS AFTER IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR DEVICE DSQ THORATEC CORP. 104911 106174

    Patients

    Seq Age Sex Outcome Treatment
    1 Death