BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2180421 · Received July 27, 2011

    Report

    Report Number
    2180421
    Event Type
    Injury
    Date Received
    July 27, 2011
    Date of Event
    June 20, 2011
    Report Date
    September 27, 2011
    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: DRIVE UNIT FAILUREADDITIONAL TEXT: POSS. BROKEN GROUND WIRE IN THE PERK LEADSPECIFIC COMPONENT(S) INVOLVED: DRIVELINE MALFUNCTIONADDITIONAL TEXT: POSS. BROKEN GROUND WIRE IN THE PERK LEADOTHER COMPONENT:CAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIEDOTHER CAUSE:INTERVENTION(S): REPLACEMENT OF OTHER COMPONENT, SPECIFYOTHER INTERVENTION :IMPLANT DEVICE TYPE: LVADMALFUNCTION DEVICE TYPE:

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: DRIVE UNIT FAILURE.SPECIFIC COMPONENT(S) INVOLVED: DRIVELINE MALFUNCTION.

    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 47.4 YR