BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3093832 · Received April 30, 2013

    Report

    Report Number
    2916596-2013-00497
    Event Type
    Injury
    Date Received
    April 30, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 1, 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 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 PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT THE PATIENT PRESENTED WITH HEART FAILURE SYMPTOMS AND ELEVATED PULSATILITY INDEX (PI). THE PUMP'S POWER IS NORMAL; HOWEVER, THE PUMP SOUNDS FUNNY. THE PATIENT WAS ADMITTED AND THE PATIENT'S LACTATE DEHYDROGENASE (LDH) INCREASED. REVIEW OF THE LOG FILE INDICATED THE PUMP'S ACTUAL SPEED WAS NOT BEING MAINTAINED THROUGHOUT THE LOG FILE. NO OTHER ABNORMAL EVENTS WERE NOTED. ADD'L INFO INDICATED THAT THE PATIENT HAD A PUMP EXCHANGE DUE TO SUSPECTED THROMBUS AND THE PATIENT HEMOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187671 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 121673

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention