BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2499452 · Received March 20, 2012

    Report

    Report Number
    2916596-2012-00235
    Event Type
    Injury
    Date Received
    March 20, 2012
    Date of Event
    February 20, 2012
    Report Date
    February 20, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVALUATION. 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). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT HAD A POSSIBLE PUMP POCKET INFECTION THAT THEY WERE UNABLE TO RESOLVE. A PUMP EXCHANGE FROM ONE LVAD TO ANOTHER LVAD WAS PLANNED AND PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 1355 77310

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention