BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE XVE LVAS

    MDR report key: 1870924 · Received October 7, 2010

    Report

    Report Number
    2916596-2010-00252
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 10, 2010
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR REPORTED THAT THE PT WAS HAVING INCREASED DUST IN THE VENT FILTER AND THEY WANTED TO PLAN A PUMP EXCHANGE. A PLANNED PUMP EXCHANGE OCCURRED ON (B)(6)2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE XVE LVAS XVE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 1270 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention