BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2890505 · Received December 26, 2012

    Report

    Report Number
    2916596-2012-01261
    Event Type
    Injury
    Date Received
    December 26, 2012
    Date of Event
    February 6, 2012
    Report Date
    December 4, 2012
    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 PT REMAINS ON GOING WITH THE IMPLANTED DEVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR¿S INVESTIGATION IS COMPLETED. THE USER FACILITY REPORT WAS RECEIVED FROM THE (B)(6) REGISTRY.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE MFR RECEIVED A USER FACILITY REPORT RECEIVED FROM THE (B)(6) REGISTRY WHICH STATED: ¿PT ADMITTED TO THE HOSPITAL FOR DEVICE THROMBOSIS.¿ ¿HAD TISSUE PLASMINOGEN ACTIVATOR PROTOCOL INITIATED. PATIENT TOLERATED WELL. DISCHARGED SIX DAYS LATER¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 84561

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention