BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2498051 · Received March 15, 2012

    Report

    Report Number
    2916596-2012-00234
    Event Type
    Malfunction
    Date Received
    March 15, 2012
    Date of Event
    February 15, 2012
    Report Date
    February 15, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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.

    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 SHOWING SIGNS OF RIGHT HEART FAILURE. A TEE AND X-RAY WERE PERFORMED WHERE TAPENADE AND BEND RELIEF DISLODGEMENT WERE CONFIRMED. IT IS BELIEVED THAT PERICARDIAL EFFUSION LED TO TAPENADE AND WORSENING RIGHT VENTRICULAR FAILURE WITH PRESSURE LEADING TO BEND RELIEF DISLODGEMENT. THE PT WAS RETURNED TO THE OPERATING ROOM WHERE THE TAPENADE WAS FIXED AND THE BEND RELIEF WAS ATTACHED TO THE ELBOW WITH SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 107488

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening