BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3223931 · Received July 8, 2013

    Report

    Report Number
    2916596-2013-00863
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 13, 2013
    Report Date
    June 14, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL 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) REPORT WAS RECEIVED WHICH INDICATED THAT THE PT HAD A CONTINUOUS INCREASE IN LACTATE DEHYDROGENASE (LDH) ABOVE 1000 AND INCREASE IN BILIRUBIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309083 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 122478

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other