BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2512336 · Received March 28, 2012

    Report

    Report Number
    2916596-2012-00262
    Event Type
    Injury
    Date Received
    March 28, 2012
    Date of Event
    February 24, 2012
    Report Date
    February 28, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR, 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 COORD THAT THE PT PRESENTED TO THE CLINIC WITH ELEVATED LDH LEVELS. THE PT WAS PUT ON THE 1A TRANSPLANT LIST DUE TO HEMOLYSIS AND RECEIVED A HEART TRANSPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 108898

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention