BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3850435 · Received May 15, 2014

    Report

    Report Number
    2916596-2014-00779
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 16, 2014
    Report Date
    April 16, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC CAUSE FOR THE REPORT OF POWER ELEVATIONS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. THE PATIENT REMAINS ONGOING ON LVAD SUPPORT. IT WAS REPORTED THAT THE POWER ISSUES RESOLVED AFTER THE PATIENT WAS DIURESED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    A PORTION OF THE PERCUTANEOUS LEAD WAS RETURNED TO THE MANUFACTURER FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT ALL POWER RELATED ISSUES RESOLVED AFTER DIURESING 25 LBS OF FLUID OVER THE COURSE OF 10 DAYS FROM THE PATIENT. THERE WERE NEVER ANY SYMPTOMS OF HEMOLYSIS. THE PATIENT WAS NEGATIVE FOR PLASMA FREE HEMOGLOBIN AND HAD NORMAL READINGS FOR LACTATE DEHYDROGENASE(LDH), HAPTOGLOBIN, HEMATOCRIT AND SCHISTOCYTES. THE PATIENT'S KIDNEY FUNCTION WAS NEVER IMPACTED BY EITHER THE POWER CONSUMPTION OF THE LVAD OR THE DIURESIS.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE VAD COORDINATOR REPORTED THAT THE PT WAS IN THE OUTPATIENT CLINIC FOR A SYSTEM CONTROLLER EXCHANGE. THE PT'S SYSTEM CONTROLLER WAS EXCHANGED, BUT HE EXPERIENCED A RED HEART ALARM. THE PT WAS THEN SWITCHED TO THE NEW BACK UP CONTROLLER AND THAT ALSO ALARMED RED HEART WITH LOW FLOWS. THE PT WAS ADMITTED TO THE HOSP. THE PERCUTANEOUS LEAD WAS EVALUATED AND THE DISTAL END BEND RELIEF WAS STARTING TO SEPARATE FROM THE METAL CONNECTOR. THERE WAS SUSPECTED WIRE DAMAGE AT OR NEAR THE DISTAL END BEND RELIEF. AN X-RAY WAS COMPLETED AND SHOWED A POSSIBLE INTERNAL DRIVELINE FRACTURE. A DISTAL END PERCUTANEOUS LEAD REPLACEMENT WAS PERFORMED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291571 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 134131

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention