BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 1971519 · Received January 21, 2011

    Report

    Report Number
    2916596-2011-00028
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    December 20, 2010
    Report Date
    December 28, 2010
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS IN THE SKILLED NURSING FACILITY WITH THE IMPLANTED DEVICE IN PLACE, BUT TURNED OFF. 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). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT WAS EXPERIENCING LOW SPEED ALARMS WHEN SITTING UP OR BENDING. THE PERC LEAD WAS MANIPULATED AND NO FAILURES WERE REPORTED. THEY BELIEVE THE LOW SPEED ALARMS MAYBE CAUSED BY SOMETHING INTERNAL. WAVEFORMS SHOW SEVERAL LOW SPEED DROPS AND POWER SPIKES WITHIN A 1.5 HOUR TIMEFRAME. THE PATIENT APPEARS TO BE FINE AS LONG AS THEY ARE LYING FLAT OR STANDING. THE FOLLOWING DAY, THE PATIENT WAS TAKEN TO THE OPERATING ROOM WHERE THE PUMP WAS TURNED OFF, THE PERC LEAD CUT AND THE OUTFLOW GRAFT CLAMPED, HOWEVER, THE PUMP WAS NOT EXPLANTED, BUT WAS TURNED OFF. ONE WEEK LATER, THE PATIENT WAS DISCHARGED TO A SKILLED NURSING FACILITY WITH THE PUMP STILL IN PLACE BUT TURNED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 1355 88799

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention