BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4100889 · Received September 12, 2014

    Report

    Report Number
    2916596-2014-01605
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    August 11, 2014
    Report Date
    August 13, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. 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 ON (B)(6) 2014 THAT THE PATIENT'S LDH HAD ELEVATED TO 1324 (HE RANGES FROM THE 500-900'S), AND HIS URINE WAS DARK BROWN. THE PATIENT HAD ALSO BEEN EXPERIENCING LEFT-SIDED CHEST DISCOMFORT SINCE (B)(6) 2014. THE PATIENT WAS ADMITTED FOR FURTHER EVALUATION. ON (B)(6) 2014, THE VAD COORDINATOR REPORTED THAT WHEN THE PATIENT WAS ADMITTED HE HAD AN ECHO, CT ANGIOGRAPHY WITH 3D RECONSTRUCTION AND ALL WERE WITHIN NORMAL LIMITS. LABS WERE DRAWN (HAPTOGLOBIN, IRON STUDIES, SERIAL LDH ETC.) AND THE PATIENT WAS NOT CLINICALLY COMPROMISED AND WAS TOLD TO INCREASE HIS FLUIDS. THE PATIENT WAS THEN DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566105 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 138979

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention