BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3003939 · Received March 12, 2013

    Report

    Report Number
    2916596-2013-00257
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 13, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE ADDITIONAL INFORMATION FROM THE HOSPITAL REGARDING THE EVENT AND THE PRODUCT DISPOSITION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE MANUFACTURER RECEIVED A REPORT THROUGH DEVICE TRACKING INDICATING THAT, AFTER 7 MONTHS OF SUPPORT, THE HOSPITAL HAD EXCHANGED THE PATIENT'S PUMP WITH ANOTHER LVAD. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103499 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 116896

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention