BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4142712 · Received October 2, 2014

    Report

    Report Number
    2916596-2014-01755
    Event Type
    Injury
    Date Received
    October 2, 2014
    Date of Event
    August 25, 2014
    Report Date
    September 4, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO THE MFR 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). IT WAS REPORTED BY THE PERFUSIONIST THAT THE PT PRESENTED TO THE HOSP WITH SHORTNESS OF BREATH AND HEMATURIA. THE PT WAS REPORTEDLY TAKEN TO THE OR FOR AN IMMEDIATE PUMP REPLACEMENT DUE TO THE PRESENCE OF A CLOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614848 HEARTMATE II LVAS Ventricular (assist) bypass DSQ THORATEC CORP. 104911 126035

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention