BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3780711 · Received April 21, 2014

    Report

    Report Number
    2916596-2014-00616
    Event Type
    Injury
    Date Received
    April 21, 2014
    Date of Event
    March 23, 2014
    Report Date
    March 24, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE MANUFACTURER'S INVESTIGATION.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT THE PT WAS ADMITTED TO A LOCAL HOSPITAL DUE TO HERNIA. THE PT RECEIVED A TRANSFUSION. AS OF (B)(6) 2014, IT WAS REPORTED THAT THE PT WAS STILL HOSPITALIZED IN THE ICU AT THE LOCAL HOSPITAL AND SHE REFUSES TO GO BACK TO THE IMPLANTING CENTER. THE VAD COORDINATORS AT THE IMPLANTING CENTER WERE NOTIFIED OF THE PT'S STATUS. THE PT IS CURRENTLY LISTED AS DO NOT RESUSCITATE (DNR). THE PT'S LAB RESULTS WERE MONITORED. IT WAS NOTED THAT THE PT IS CURRENTLY BEING MONITORED IN THE ICU. NO OTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241327 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 93331

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention