BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3911685 · Received May 28, 2014

    Report

    Report Number
    2916596-2014-00852
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    March 29, 2014
    Report Date
    April 28, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IN USE SUPPORTING THE PT. NO FURTHER INFO IS AVAILABLE THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT WAS ADMITTED INTO THE HOSPITAL ON (B)(6) 2014 WITH GI BLEEDING. THE PT WAS STABILIZED AND DISCHARGED TO HOME ON (B)(6) 2014. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314545 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 107656

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention