BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3911667 · Received May 28, 2014

    Report

    Report Number
    2916596-2014-00838
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 28, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IN USE SUPPORTING THE PT. 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

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT WAS ADMITTED INTO THE HOSPITAL WITH LDH OF 629 (BASELINE 220'S). THE PT HAD BEEN ON HIGH DOSE HEPARIN NOMOGRAM, ASA 325, AND DIPYRIDAMOLE 75 TID. IT WAS REPORTED APPROXIMATELY 3 WEEKS LATER THAT THE PT WAS STILL IN HOSPITAL DUE TO HEMOLYSIS. HIS LDH WAS UP TO 900 WITH POWER ELEVATIONS. THE LDH HAD BEEN AS LOW AS THE 400'S BUT WAS TRENDING BACK UPWARD. IT WAS ALSO REPORTED THAT THE PT HAD GAINED 40 LBS. THE PT IS CURRENTLY BEING TREATING WITH HEPARIN IV, FULL ASPIRIN AND INR GOA OF 2.5-3.5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314216 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 129242

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention