BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2960791 · Received February 11, 2013

    Report

    Report Number
    2916596-2013-00168
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    January 13, 2013
    Report Date
    January 13, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ONGOING WITH THE IMPLANTED DEVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED. 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. IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT HAS PERSISTENT PERCUTANEOUS LEAD INFECTION WITH SUSPECTED PUMP INFECTION. PURULENT DISCHARGE AND DRAINAGE COMING FROM THE PERCUTANEOUS LEAD. POSSIBLE PUMP POCKET INFECTION IS SUSPECTED. CAT SCAN (CT) ORDERED AND PATIENT STARTED ON IV ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59292 HEARTMATE II LVAD LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 114398

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention