BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 1801481 · Received August 16, 2010

    Report

    Report Number
    1801481
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    May 16, 2010
    Report Date
    October 15, 2010
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: EXTERNAL CONTROL SYSTEM FAILURE.SPECIFIC COMPONENT(S) INVOLVED: OTHER COMPONENT MALFUNCTION.

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: EXTERNAL CONTROL SYSTEM FAILURE. ADDITIONAL TEXT: POWER MODULE WOULD NOT STOP ALARMING. SPECIFIC COMPONENT(S) INVOLVED: OTHER COMPONENT MALFUNCTION, SPECIFY. ADDITIONAL TEXT: OTHER COMPONENT: POWER MODULE. CAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIED. OTHER CAUSE: INTERVENTION(S): REPLACEMENT OF OTHER COMPONENT, SPECIFY. OTHER INTERVENTION : IMPLANT DEVICE TYPE: LVAD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58.5 YR