BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2800354 · Received October 18, 2012

    Report

    Report Number
    2916596-2012-01008
    Event Type
    Death
    Date Received
    October 18, 2012
    Date of Event
    March 17, 2012
    Report Date
    September 21, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INFO PROVIDED TO THE MFR, THE EXPLANTED LVAD WAS DISPOSED OF BY THE HOSPITAL. NO FURTHER INFO IS AVAILABLE AT THIS 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 A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT THE PT PRESENTED TO THE CLINIC WITH LOW BLOOD PRESSURE AND A MASSIVE DRIVELINE INFECTION THAT RESULTED IN SEPSIS. THE PT REPORTEDLY HAD A HISTORY OF CHRONIC DRIVELINE INFECTIONS (AS A RESULT OF BEING NON-COMPLIANT WITH STERILE DRESSING CHANGES) AND HAD RECENTLY STOPPED TAKING HIS PO (ORAL) ANTIBIOTICS. THE PT WAS ADMITTED FROM THE CLINIC FOR THE ADMINISTRATION OF IV ANTIBIOTICS; HOWEVER, THE INFECTION CONTINUED AS IT WAS RESISTANT TO ANTIBIOTICS. THE PT SUBSEQUENTLY EXPIRED FROM SEPTICEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 83434

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death