BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3053383 · Received April 11, 2013

    Report

    Report Number
    3053383
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 25, 2013
    Report Date
    April 4, 2013
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RED HEART ALARMED, CONTROLLER CHANGED OUT. HEP GTT AND HOSPITALIZED. RAMP ECHO DONE. NO EVIDENCE OF OBS. SPRING WAS BROKEN ON PERC LEAD OF HIS BACKUP CONTROLLER. BOTH CONTROLLERS SENT TO THORATEC FOR REVIEW. NO FX OR BREAKS IN PERC LEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155678 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1