BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3945102 · Received July 18, 2014

    Report

    Report Number
    3945102
    Event Type
    Injury
    Date Received
    July 18, 2014
    Date of Event
    April 4, 2014
    Report Date
    July 15, 2014
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ABRUPT PUMP STOP ON (B)(6). SUSP PUMP MALFX/THROMBOSIS. INTEGRILIN START & CONTROLLER REPLACED. (B)(6) GIB. INTEGRILIN STOPPED. (B)(6) SHE HAD A RETROPERITONEAL BLEED A/W EXTREME PAIN. SEDATION LED TO BP DROP AND ANURIA. SUPPORT WITHDRAWN ON 4/4. PRIMARY COD: WITHDRAWAL OF SUPPORT, SPECIFY DEATH DUE TO DEVICE MALFUNCTION: UNKNOWN PATIENT DEATH DATE: (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421887 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1