BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

    MDR report key: 3111358 · Received May 9, 2013

    Report

    Report Number
    2916596-2013-00568
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    February 5, 2013
    Report Date
    April 11, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PVAD LVAD REMAINS IN USE SUPPORTING THE PT. (REFERENCE MFR REPORT # 0002916596-2013-00564 FOR PVAD RVAD.) NO FURTHER INFO IS AVAILABLE AT THE 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 BIVENTRICULAR SUPPORT (PVAD LVAD AND PVAD RVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT IS EXPERIENCING AN INFECTION (PSEUDOMONAS BACTEREMIA) AND IS BEING TREATED WITH ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204793 THORATEC VENTRICULAR ASSIST DEVICE (VAD) SYSTEM DSQ: VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 14086-2550-000 88530

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention