BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 1913542 · Received December 3, 2010

    Report

    Report Number
    1913542
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    October 12, 2010
    Report Date
    April 20, 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: SPEAKER ON SYSTEM CONTROLLER IS FAINT, PERC LOCK BUTTON STICKS.SPECIFIC COMPONENT(S) INVOLVED: DRIVELINE MALFUNCTION; OTHER COMPONENT MALFUNCTION, SPECIFYADDITIONAL TEXT: TEARS NOTED IN DRIVELINE, WIRES INTACT.OTHER COMPONENT: SILICONE CASING HAS MANY TEARS NOTED, WIRES ARE INTACTCAUSATIVE OR CONTRIBUTING FACTOR: PATIENT NONCOMPLIANCE IN DEVICE MAINTENANCE AND PROTECTION; PATIENT ERROR IN CARING FOR SYSTEMOTHER CAUSE:INTERVENTION(S): REPLACEMENT OF EXTERNAL CONTROLLER; OTHER INTERVENTIONS, SPECIFYOTHER INTERVENTION : THORATEC REPAIRED DRIVELINE WITH RESCUE TAPE.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; 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 23.6 YR