BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2950599 · Received February 5, 2013

    Report

    Report Number
    2916596-2013-00137
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    December 19, 2012
    Report Date
    January 7, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORT WAS REC'D FROM THE (B)(4) REGISTRY. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). AN (B)(4) REGISTRY REPORT WAS REC'D WHICH STATED THAT THE PT WAS ADMITTED DUE TO PLASMA FREE HEMOGLOBIN AND ELEVATED LACTATE DEHYDROGENASE (LDH) WHICH INDICATED A POSSIBLE PUMP CLOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47893 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 118140

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention