BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 1882741 · Received October 13, 2010

    Report

    Report Number
    2916596-2010-00258
    Event Type
    Malfunction
    Date Received
    October 13, 2010
    Date of Event
    August 17, 2010
    Report Date
    October 12, 2010
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MFR AND THE INVESTIGATION WAS COMPLETED. THE REPORTED EVENT WAS DUPLICATED DURING ANALYSIS. THE BLACK POWER LEAD WAS FOUND TO HAVE DAMAGED/SEVERED CONDUCTORS AT THE CONNECTOR END. MOVEMENT OF THE BLACK POWER LEAD AT THE CONNECTOR END RESULTED IN "CABLE DISCONNECT" ALARMS, AS WELL AS INTERRUPTION IN PUMP SUPPORT WHILE TETHERED TO THE POWER MODULE. A REVIEW OF DEVICE MODULE RECORDS FOR THIS CONTROLLER SHOWED NO DEVIATIONS FROM MFG OR QA SPECS. 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. THE VAD COORDINATOR REPORTED THAT THE SYSTEM CONTROLLER DISPLAYED A "REPLACE SYSTEM CONTROLLER" MESSAGE ON THE DISPLAY MODULE. THE SYSTEM CONTROLLER WAS EXCHANGED AND THE EVENT WAS RESOLVED.

    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 61 YR Required Intervention