BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3962674 · Received July 16, 2014

    Report

    Report Number
    2916596-2014-01098
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 16, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ONGOING WITH THE IMPLANTED DEVICE. 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. THE VAD COORDINATOR REPORTED THAT THE PT WAS ADMITTED FOR DEHYDRATION AND ANEMIA. THE PT'S HEMOGLOBIN WAS FOUND TO BE LOW. THE PT HAD AN INCREASED LDH, WHICH NORMALIZED. VAD COORDINATOR REPORTS THAT PT HAD NO SIGNS OF HEMATURIA AND NO SIGNIFICANT CHANGES IN LVAD PARAMETERS. PATIENT WAS BEING WORKED UP FOR UPPER AND LOWER GI. GI BLEEDING WAS REPORTED AND RESULTS ARE PENDING. THE VAD COORDINATOR REPORTED THAT THE PT WAS GIVEN BLOOD TRANSFUSIONS AND HEMOGLOBIN VALUES WERE NORMAL PRIOR TO PT DISCHARGE. PT WAS DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415513 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 109238

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention