BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE XVE LVAS

    MDR report key: 1062091 · Received June 18, 2008

    Report

    Report Number
    2916596-2008-00075
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 23, 2008
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PT REMAINS ONGOING WITH THE MFR'S LVAD. THE MFR IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVAL. NO FURTHER INFO IS AVAILABLE AT THIS TIME. AND SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A VENTED ELECTRIC LEFT VENTRICLE ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE CLINICAL ENGINEER THAT THE PT CAME IN FOR A CLINIC VISIT AND STATED THAT HE HAD BEEN EXPERIENCING MULTIPLE READ HEART ALARMS FOR A COUPLE OF DAYS AND THAT THE PUMP HAD INTERMITTENTLY STOPPED. THE CLINICAL ENGINEER NOTED THAT THERE WAS EXCESSIVE BLACK DUST IN THE VENT FILTER. A DECISION WAS THEN MADE TO EXCHANGE THE PUMP, AND THE FOLLOWING DAY THE PT'S LVAD WAS REPLACED WITH ANOTHER LVAD. THE PT REMAINS ONGOING WITH THE MFR'S LVAD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention