BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2023259 · Received February 15, 2011

    Report

    Report Number
    2916596-2011-00112
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 17, 2011
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT WAS EXPERIENCING PUMP STOPPAGES WHEN CONNECTED TO THE POWER MODULE. NO ALARMS OR PUMP STOPPAGES WERE REPORTED WHEN THE PT WAS ON BATTERIES. THE PT WAS ADMITTED DUE TO A POSSIBLE PERCUTANEOUS LEAD FRACTURE. THE MANUFACTURER'S TECHNICAL SERVICE PERSONNEL WERE DISPATCHED TO THE HOSPITAL TO MAKE AN EVALUATION OF THE REPORTED EVENT. SUBSEQUENT TESTS REVEALED EXTERNAL AND INTERNAL FRACTURES NECESSITATING A PUMP EXCHANGE. FIVE DAYS LATER, THE PUMP WAS EXCHANGED FROM ONE LVAD TO ANOTHER LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 103695 86447

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention