BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 1813504 · Received August 24, 2010

    Report

    Report Number
    1813504
    Event Type
    Injury
    Date Received
    August 24, 2010
    Date of Event
    August 11, 2010
    Report Date
    October 18, 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

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: EXTERNAL CONTROL SYSTEM FAILURE.ADDITIONAL TEXT: CONTINUAL ALARM WI YELLOW WRENCH & RED INTERAL BATTERY ALARM.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.

    Description of Event or Problem · 1

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

    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 27.2 YR