BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3934195 · Received June 27, 2014

    Report

    Report Number
    2916596-2014-01077
    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
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ONGOING ON LVAD SUPPORT AND IS UNDER MEDICAL MANAGEMENT BY THE HOSPITAL. 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). THE VAD COORDINATOR REPORTED THAT THE PATIENT WAS READMITTED FOR GASTROINTESTINAL (GI) BLEEDING AND AN ONGOING INFECTION (BACTEREMIA FROM DRIVELINE INFECTION). THE PATIENT WAS REPORTEDLY ON MEROPENEM IV FOR THE INFECTION THAT WAS STOPPED PREMATURELY BY NURSING HOME. THE ANTIBIOTIC TREATMENT WAS RESTARTED AND THE PATIENT REMAINS ON MEDICAL MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378330 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 116730

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention