BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 2894216 · Received December 27, 2012

    Report

    Report Number
    2916596-2012-01239
    Event Type
    Injury
    Date Received
    December 27, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 3, 2012
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LVAD WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. THE USER FACILITY REPORT WAS RECEIVED FROM THE INTERMACS REGISTRY. 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. THE PT PRESENTED WITH HEART FAILURE SYMPTOMS WITH AN INCREASED LDH AND DARK URINE. AN ECHO WAS DONE AND DESPITE INCREASING SPEED, THE HEART WAS NOT UNLOADING. MEDICATION WAS INITIATED FOR SUSPECTED THROMBOSIS. THE PT RECEIVED A PUMP EXCHANGE ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911 114713

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention