BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE XVE LVAS

    MDR report key: 1162824 · Received September 16, 2008

    Report

    Report Number
    2916596-2008-00130
    Event Type
    Injury
    Date Received
    September 16, 2008
    Date of Event
    August 22, 2008
    Report Date
    August 22, 2008
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT REMAINS ONGOING WITH THE LVAD. THE EXPLANTED DEVICE WAS SENT TO THE MFR FOR EVALUATION. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS 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 VAD COORDINATOR THAT THE PATIENT HAD BEEN HEARING "CLACKING AND PINGING" FROM THE LVAD, AND THE PATIENT FELT THAT IT WAS A CHANGE IN THE NORMAL SOUND OF THE PUMP. THE PATIENT DID NOT EXPERIENCE ANY ALARM OR OTHER CHANGES WITH THE DEVICE. VENT FILTERS HAD BEEN ANALYZED AND A WAVEFORM WAS TAKEN AND REVIEWED, AND IT WAS DETERMINED THAT END OF LIFE ISSUES WERE OCCURRING WITH THE PUMP. AS A RESULT, A DECISION WAS MADE TO EXCHANGE THE PUMP, AND THE PATIENT'S LVAD WAS REPLACED WITH ANOTHER LVAD. THE PATIENT REMAINS ONGOING WITH THE LVAD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention