BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 1971615 · Received January 25, 2011

    Report

    Report Number
    2916596-2011-00031
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    December 19, 2010
    Report Date
    December 28, 2010
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVAL. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LAVD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT'S PUMP SPEED HAD BEEN INCREASED TO COMPENSATE FOR THE FLOW OF SUSPECTED KINKS IN THE INFLOW AND OUTFLOW CANNULAE. DUE TO THE SUSPECTED KINKS IN THE CANNULAE, THE PT WAS PUT ON THE A1 TRANSPLANT LIST AND WAS TRANSPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 84772

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention