BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2122031 · Received May 24, 2011

    Report

    Report Number
    2916596-2011-00216
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    December 22, 2010
    Report Date
    May 4, 2011
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MFR FOR EVAL AND THE REPORTED EVENT OF A "REPLACE SYSTEM CONTROLLER" MESSAGE OCCURRING WAS CONFIRMED DURING ANALYSIS. THE ANALYSIS OF THE SYSTEM CONTROLLER BLACK POWER LEAD REVEALED A COMPROMISED BROWN INNER CONDUCTOR (BATTERY FUEL GAUGE LINE). THE COMPROMISED INNER CONDUCTOR, IF SHORTED TO THE SHIELD/GROUND, WOULD RESULT IN A SYSTEM INTERRUPTION AND A REPLACE SYSTEM CONTROLLER/BACKUP MODE WHEN THE CONTROLLER IS CONNECTED TO THE POWER MODULE. 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 VAD COORDINATOR THAT THE SYSTEM CONTROLLER ALARMED AND A "REPLACE CONTROLLER" MESSAGE WAS DISPLAYED ON THE MONITOR. THE SYSTEM CONTROLLER WAS EXCHANGED W/O INCIDENT. 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 CORPORATION 103696 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other