BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE

    MDR report key: 448023 · Received March 12, 2003

    Report

    Report Number
    MW1027839
    Event Type
    Malfunction
    Date Received
    March 12, 2003
    Date of Event
    February 3, 2003
    Report Date
    March 5, 2003
    Manufacturer
    THORATEC
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT RECEIVED A HEART TRANSPLANT IN 2003. THE XVE-1437 PUMP WAS BEING PREPARED TO BE RETURNED TO THORATEC CORP FOR ROUTINE PUMP REIMBURSEMENT. UPON INSPECTION NOTICED OUTFLOW VALVE WAS CALCIFIED AND INFLOW VALVE WAS TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE VENTRICULAR ASSIST DEVICE DSQ THORATEC XVE-1437 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA