BEUDAMED
    FDA Adverse Event Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2990424 · Received March 5, 2013

    Report

    Report Number
    2990424
    Date Received
    March 5, 2013
    Date of Event
    October 1, 2012
    Report Date
    March 5, 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

    THE POWER MODULE CABLE WAS CAUSING THE PATIENT TO BE DISPLAYED AS DISCONNECTED WHILE HE WAS CONNECTED TO THE POWER MODULE. THE CABLE WAS REPLACED AND THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93697 HEARTMATE II LVAD LVAS DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1