BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2885071 · Received December 19, 2012

    Report

    Report Number
    2916596-2012-01245
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    October 29, 2012
    Report Date
    November 28, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ONGOING WITH THE IMPLANTED DEVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED. 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 READMITTED WITH COKE COLORED URINE AND LACTATE DEHYDROGENASE (LDH) LEVEL OF 2000. THE PT IS CURRENTLY ON THEIR THIRD PUMP AND DUE TO OTHER FACTORS; THE HOSPITAL DOES NOT FEEL THE PT IS A GOOD CANDIDATE FOR A PUMP EXCHANGE OR TRANSPLANT. THE PT WAS GIVEN INTEGRILIN AND HEPARIN GTTS. THE PT'S URINE CLEARED SLIGHTLY AND THE PT WAS DISCHARGED HOME ON PLAVIX AS WELL AS ASPIRIN (ASA) AND COUMADIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 110284

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Life Threatening