BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS , EUROPE

    MDR report key: 3853614 · Received April 3, 2014

    Report

    Report Number
    2916596-2014-00481
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    March 5, 2014
    Report Date
    March 5, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ON LVAD SUPPORT WITH THE PUMP. NO FURTHER INFO 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 2.5 YEARS POST-IMPLANT, IT WAS REPORTED THAT THE PT EXPERIENCED RED HEART ALARMS IN THE EVENT AND POSSIBLE UNK ALARMS IN THE PREVIOUS DAYS. THE PT'S EVENT HISTORY INDICATED PUMP STOPPAGES, ELEVATED PUMP POWER AND THE PT'S PULSATILITY INDEX (PI) WAS HIGH. A DECISION WAS MADE TO CHANGE THE PT'S PERCUTANEOUS LEAD WHICH WAS COMPLETED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203486 HEARTMATE II LVAS , EUROPE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104912 105149

    Patients

    Seq Age Sex Outcome Treatment
    1