BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3022533 · Received March 21, 2013

    Report

    Report Number
    2916596-2013-00304
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 20, 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE SURGEON SUBMITTED LOG FILES FOR A RECENTLY IMPLANTED PT DUE TO PERSISTENT TRANSIENT POWER SPIKES ON DAY 1 AFTER IMPLANT DESPITE ADEQUATE ANTI COAGULATION. ANGIOMAX WAS ADMINISTERED BY INTRAVENOUS (IV) ON DAY 2. A DECISION WAS MADE TO EXCHANGE THE PT'S PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117652 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 121301

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention