BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE XVE LVAS

    MDR report key: 1221987 · Received November 6, 2008

    Report

    Report Number
    2916596-2008-00157
    Event Type
    Injury
    Date Received
    November 6, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 16, 2008
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SUCCESSFULLY EXCHANGED WITH ANOTHER LVAD AND THE PT REMAINS ONGOING WITHOUT ANY FURTHER ISSUES. THE MFR IS ATTEMPTING TO ACQUIRE THE EXPLANTED 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 PATIENT WAS IMPLANTED WITH A VENTED ELECTRIC LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE STUDY COORDINATOR THAT THE PT HAD EXPERIENCED SOME "CRICKET NOISES" WITH NO REPORTED ALARMS FROM THE DEVICE. A VENT FILTER SAMPLE SUBMITTED TO THE MFR FOR ANALYSIS SHOWED EVIDENCE OF FOLLOWER BEARING WEAR. THE HOSPITAL MADE A DECISION TO EXCHANGE THE LVAD WITH ANOTHER LVAD, DUE TO DEVICE END OF LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE XVE LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 1270 58995

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention