BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENTRASSIST

    MDR report key: 1581151 · Received January 13, 2010

    Report

    Report Number
    MW5014364
    Event Type
    Death
    Date Received
    January 13, 2010
    Date of Event
    December 31, 2009
    Report Date
    January 5, 2010
    Manufacturer
    VENTRACOR, INC. (NOTE CO. NOW DEFUNCT)
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PT WAS AT HOME WHEN HE FELL AND SHEARED OFF THE ELECTRICAL DRIVELINE CONNECTED TO HIS IMPLANTED LEFT VENTRICULAR ASSIST DEVICE. WITHOUT THIS CONNECTIONS, THE DEVICE STOPPED. HE WAS FOUND BY HIS FAMILY UNCONSCIOUS AND APNEIC FOR APPROX 20 MINUTES, THE PT WAS TAKEN TO THE ER. PT WAS PRONOUNCED AT THE HOSPITAL. DIAGNOSIS OR REASON FOR USE: DILATED CARDIOMYOPATHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTRASSIST LEFT VENTRICULAR ASSIST DEVICE DSQ VENTRACOR, INC. (NOTE CO. NOW DEFUNCT)

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death