BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2251007 · Received September 13, 2011

    Report

    Report Number
    2916596-2011-00396
    Event Type
    Death
    Date Received
    September 13, 2011
    Date of Event
    June 9, 2011
    Report Date
    August 16, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED LVAD WAS DISPOSED OF BY THE HOSP. 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 APPROXIMATELY TEN MONTHS POST-IMPLANT OF THE LVAD, THE PT HAD BEEN HAVING ISSUES WITH THE PUMP. THE PUMP HAD REPORTEDLY STOPPED DUE TO SUSPECTED THROMBUS IN THE DEVICE; HOWEVER, THE PT HAD DECLINED FURTHER MEDICAL INTERVENTION AND WAS DISCHARGED TO HOSPICE CARE AND ULTIMATELY EXPIRED. ACCORDING TO INFO PROVIDED BY THE VAD COORDINATOR, THIS OUTCOME WAS EXPECTED BY THE HOSP GIVEN THE PT'S CLINICAL AND ANTICOAGULATION CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 91572

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death