BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3042039 · Received April 4, 2013

    Report

    Report Number
    2916596-2013-00338
    Event Type
    Death
    Date Received
    April 4, 2013
    Date of Event
    March 3, 2013
    Report Date
    March 6, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT EXPIRED. 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. THE VAD COORDINATOR REPORTED THAT THE PT WAS TRAVELING IN FLORIDA AWAY FROM THE ORIGINAL IMPLANTING CENTER. THE PT'S WIFE REPORTED THAT HE WAS WEAK. THE PT WAS EMERGENTLY TRANSPORTED AND WAS FOUND TO BE "ASYSTOLIC" UNDER THE PACED BEATS AND HE WAS PRONOUNCED DEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138733 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 116107

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death