BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3934196 · Received June 27, 2014

    Report

    Report Number
    2916596-2014-01076
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT IS ON MEDICAL MANAGEMENT AND REMAINS ONGOING ON LVAD SUPPORT. NO FURTHER INFORMATION IS AVAILABLE A 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 TO THE CENTER FOR NEW DRIVELINE INFECTION. THE PATIENT ADMITTED TO ACCIDENTALLY HAVING DRESSING REMOVED FOR AN UNKNOWN DURATION OF TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377822 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 103748

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention