BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2152475 · Received June 22, 2011

    Report

    Report Number
    2916596-2011-00257
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 24, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MFR FOR EVAL AND THE REPORTED ALARMS WERE CONFIRMED DURING ANALYSIS. DURING FUNCTIONAL TESTING, MOVEMENT OF THE BLACK POWER LEAD AT THE CONNECTOR END RESULTED IN A LOW BATTERY AND A RED HEART ALARM. UPON FURTHER EVAL, THE BLACK POWER LEAD WAS FOUND TO HAVE A COMPROMISED BROWN CONDUCTOR (BATTERY FUEL GAUGE LINE) AT THE CONNECTOR END. THIS SITUATION IS BEING ADDRESSED THROUGH THE MFR'S CORRECTIVE/PREVENTATIVE ACTION SYSTEM AND AN URGENT MEDICAL DEVICE CORRECTION NOTICE (29165969/2/10001-C) WAS SENT TO CUSTOMERS. NO FURTHER INFO IS AVAILABLE. THE MFR IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE CIRCULATORY SUPPORT SPECIALIST THAT INTERMITTENT BEEPS WERE OCCURRING WITH THE SYSTEM CONTROLLER. THE SYSTEM CONTROLLER WAS EXCHANGED AND THE ISSUE WAS RESOLVED. THE PT REMAINS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER LVAD SYSTEM CONTROLLER DSQ THORATEC CORP. 103696 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other