BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3042192 · Received April 4, 2013

    Report

    Report Number
    2916596-2013-00376
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    February 15, 2013
    Report Date
    March 6, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED PUMP WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT THE PT WAS ADMITTED TO THE HOSP WITH AN UNK COMPLAINT AND IT WAS NOTED THAT PUMP POWER WAS ELEVATED. THE PT'S LAB WORK SHOWED ELEVATED PLASMA FREE HEMOGLOBIN (PFHG) ALONG WITH SYMPTOMS OF HEMATURIA AND ANEMIA. THE HOSP SUBSEQUENTLY MADE A DECISION TO EXPLANT THE LVAD AND THE PT WAS IMPLANTED WITH A DEVICE FROM ANOTHER MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139197 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 107485

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention