BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 2122020 · Received May 24, 2011

    Report

    Report Number
    2916596-2011-00217
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    March 22, 2011
    Report Date
    May 3, 2011
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR FOR EVAL. THE SYSTEM CONTROLLER WAS CONNECTED TO THE EQUIPMENT IN THE MFR'S LAB AND THE REPORT OF YELLOW BATTERY ALARMS WAS CONFIRMED DURING ANALYSIS. THE WHITE POWER CABLE WAS MANEUVERED AND THE LOW VOLTAGE ALARM BECAME ACTIVE. THE WHITE POWER CABLE WAS THEN STRIPPED AT THE CONNECTOR END AND REVEALED A BROKEN CONDUCTOR. THIS SITUATION IS BEING ADDRESSED THROUGH THE MFR'S CORRECTIVE/PREVENTIVE 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 HOSPITAL PERSONNEL THAT THE PT'S SYSTEM CONTROLLER ALARMS WHEN BENDING THE WHITE POWER LEAD AT THE CONNECTOR END. THE SYSTEM CONTROLLER WAS EXCHANGED FOR ANOTHER SYSTEM CONTROLLER AND NO FURTHER EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER LVAD SYSTEM CONTROLLER DSQ THORATEC CORPORATION 103696 90836

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other