BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4100875 · Received September 12, 2014

    Report

    Report Number
    2916596-2014-01604
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 12, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT WAS ADMITTED INTO THE HOSPITAL FOR A HEAD BLEED. THE PATIENT IS ONGOING AND IS BEING TREATED FOR (B)(6). THE HEAD BLEED WAS SPONTANEOUS. THE PATIENT IS DOING WELL AND WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566196 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 133950

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention