BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2030031 · Received March 25, 2011

    Report

    Report Number
    2030031
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    March 21, 2011
    Report Date
    June 7, 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: BLOOD PUMP. ADDITIONAL TEXT: PUMP FAILURE FOR < 1 MINUTE DUE TO POSSIBLE GROUNDING ISSUES. SPECIFIC COMPONENT(S) INVOLVED: DRIVELINE MALFUNCTION. ADDITIONAL TEXT: POSSIBLE GROUNDING ISSUE. OTHER COMPONENT: CAUSATIVE OR CONTRIBUTING FACTOR: NO SPECIFIC CONTRIBUTING CAUSE IDENTIFIED. OTHER CAUSE: INTERVENTION(S): OTHER INTERVENTIONS, SPECIFY. OTHER INTERVENTION : REPLACEMENT OF THE PATIENT PM CABLE WITH A SPECIAL ONE. IMPLANT DEVICE TYPE: LVAD.

    Description of Event or Problem · 1

    MAJOR PUMP UNIT(S) INVOLVED: BLOOD PUMPSPECIFIC 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 28 YR