BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE XVE LVAS

    MDR report key: 1062085 · Received June 16, 2008

    Report

    Report Number
    2916596-2008-00074
    Event Type
    Injury
    Date Received
    June 16, 2008
    Date of Event
    May 18, 2008
    Report Date
    May 18, 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 PATIENT REMAINS STABLE ON PNEUMATIC SUPPORT AND IS AWAITING HEART TRANSPLANT. 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 VAD COORDINATOR THAT WHILE THE PT WAS AT HOME, THE SYSTEM CONTROLLER "BEEPED". THE PATIENT THEN TRIED TO CHANGE HIS BATTERIES AND THE SYSTEM CONTROLLER "BEEPED" AGAIN AND THEN THE PUMP STOPPED. THE PT CALLED 911 AND HAND PUMPED HIMSELF AND WAS TAKEN TO THE HOSP. RED HEART, YELLOW WRENCH AND CURRENT LIMIT ADVISORY ALARMS HAD OCCURRED AND THE SYSTEM CONTROLLER WAS EXCHANGED. THE PT WAS PLACED ON PNEUMATIC SUPPORT USING A STROKE VOLUME LIMITER (SVL) AND DRIVE CONSOLE, AND WAS TRANSFERRED TO ANOTHER HOSP WHERE HE REMAINS STABLE AWAITING A HEART TRANSPLANT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention