BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2780643 · Received October 5, 2012

    Report

    Report Number
    2916596-2012-00944
    Event Type
    Injury
    Date Received
    October 5, 2012
    Date of Event
    September 13, 2012
    Report Date
    September 13, 2012
    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 PT HAS BEEN DISCHARGED FROM THE HOSPITAL AND CONTINUES ON LVAD SUPPORT. THE EXPLANTED DEVICE WAS RETURNED TO THE MFR FOR EVAL 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). THE VAD COORDINATOR REPORTED THAT THE PT HAD A RED HEART ALARM THAT EVENTUALLY WENT AWAY. THE ALARM OCCURRED WHILE PATIENT WAS ON THE POWER MODULE. THE PT¿S HISTORICAL LOG FILE DATA WAS REVIEWED AND CONFIRMED PUMP STOPS WHICH WERE REPRODUCED WITH MANIPULATION OF THE PERCUTANEOUS LEAD NEAR THE EXIT SITE. THE PT HAD A PUMP EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 96980

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention