BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3020583 · Received March 21, 2013

    Report

    Report Number
    2916596-2013-00295
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    February 16, 2013
    Report Date
    February 20, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ONGOING ON LVAD SUPPORT AND NO FURTHER ISSUES HAVE BEEN REPORTED. 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 VAD COORDINATOR REPORTED THAT 2 DAYS POST IMPLANTATION OF THE LVAD, THE PATIENT EXPERIENCED SEIZURES AND HAD A POSITIVE CEREBROVASCULAR ACCIDENTS (CVA) CONFIRMED BY CT SCAN. THE PATIENT HAD A REDO STERNOTOMY, WAS REPORTEDLY VERY UNSTABLE PRIOR TO THE SURGERY AND A HIGH RISK FOR THE PROCEDURE. A REVIEW OF THE LOG FILE DATA SUBMITTED TO THE MANUFACTURER FOR ANALYSIS REVEALED 2 RECORDED EVENTS OF POWER ELEVATIONS ABOUT 10 WATTS WHICH APPEARED TO BE ASSOCIATED WITH PI EVENTS. MAJORITY OF THE EVENTS CAPTURED IN THE LOG FILE WERE PI EVENTS. MAJORITY OF THE EVENTS CAPTURED IN THE LOG FILE WERE PI EVENTS. THERE WAS A SLIGHT UPTREND IN POWER WHICH, NEAR THE END OF THE LOG FILE, APPEARED TO DOWNTREND BACK TOWARDS 7-8 WATTS. UPDATED INFORMATION PROVIDED TO THE MANUFACTURER INDICATED THAT THE HOSPITAL WAS LOOKING TO DISCHARGE THE PATIENT TO A REHAB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118810 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 119952

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other