BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3042164 · Received April 4, 2013

    Report

    Report Number
    2916596-2013-00390
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    January 8, 2013
    Report Date
    March 7, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IN USE SUPPORTING THE PATIENT. NO ADDITIONAL INFORMATION 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 PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). APPROXIMATELY 11 MONTHS POST IMPLANT, THE PATIENT WAS ADMITTED DUE TO SIGNS OF A TRANS-ISCHEMIC ATTACK. IT WAS STATED THAT THE PATIENT EXPERIENCED TINGLING, SLIGHT WEAKNESS AND SLIGHT CONFUSION. THE PATIENT WAS "WORKED UP" FOR POSSIBLE HEMOLYSIS, HOWEVER NONE WAS FOUND. THE PATIENT'S DAILY ASPIRIN DOSAGE WAS INCREASED. HE REPORTEDLY HAD NO RESIDUAL EFFECTS FROM THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138161 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 107658

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization