BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2923384 · Received January 22, 2013

    Report

    Report Number
    2923384
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 22, 2011
    Report Date
    January 16, 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

    GREENISH DRAINAGE FROM PERC LEAD CONNECTION SITE TO CONTROLLER, SECONDARY TO TEAR IN LEAD COVERAGE/BREAK AT PEBR SITE. LVAD MALFUNCTION -> LEAD EXPOSURE -> BREAKUP IN LEAD COVERING. LISTED AS STATUS 1A -> TRANSPLANT (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30637 HEARTMATE II LVAS LVAD DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1