BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 3022986 · Received March 21, 2013

    Report

    Report Number
    2916596-2013-00306
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    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. THE PUMP REMAINS IMPLANTED AND IN USE BY THE PT. NO FURTHER INFORMATION 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. DURING AN OUTPATIENT VISIT, THE PERCUTANEOUS LEAD WAS TESTED BY THE MFR'S TECHNICAL SERVICE REP. ALTHOUGH ALL CONDUCTORS WITHIN THE PERCUTANEOUS LEAD WERE FOUND TO BE INTACT, THE VAD COORDINATOR AT THE HOSPITAL DECIDED TO OPEN THE OUTER SILICONE OF THE PERCUTANEOUS LEAD APPROX 10CM FROM THE EXIT SITE AND DISCOVERED FLUID INSIDE, INDICATING POSSIBLE DAMAGE TO THE INTRACORPOREAL PORTION OF THE PERCUTANEOUS LEAD, ALLOWING FLUID TO ENTER. IT WAS REPORTED THAT THE VAD COORDINATOR WILL RECOMMEND A PUMP EXCHANGE AT SOME POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118984 HEARTMATE II LVAS, EUROPE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 102139 77343

    Patients

    Seq Age Sex Outcome Treatment
    1