BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2151509 · Received June 21, 2011

    Report

    Report Number
    2916596-2011-00251
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 23, 2011
    Report Date
    May 23, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION 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 PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE PERFUSIONIST REPORTED THAT THE PATIENT WAS EXPERIENCING RED HEART ALARMS WHILE ON TETHERED SUPPORT. POSITIONAL PUMP STOPPAGE WAS REPORTEDLY OBSERVED WHILE THE PATIENT WAS IN THE HOSPITAL. INITIAL X-RAYS OF THE DRIVELINE TAKEN BY THE HOSPITAL WERE UNREMARKABLE. AN EVALUATION OF THE LOG FILE DATA BY THE MANUFACTURER INDICATED THAT THE LVAD WAS STRUGGLING TO KEEP THE SET SPEED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND APPEARED STABLE ON BATTERY SUPPORT. THE MANUFACTURER HAS PROVIDED THE HOSPITAL WITH A NON-GROUNDED PATIENT CABLE FOR THE PATIENT'S USE PENDING FURTHER EVALUATION OF THE LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 93424

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention