BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER, EU

    MDR report key: 2180640 · Received May 5, 2011

    Report

    Report Number
    2916596-2011-00180
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    February 17, 2011
    Report Date
    April 11, 2011
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Removal / Correction Number
    2916596/2/10001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM CONTROLLER WAS RETURNED TO THE MANUFACTURER FOR EVAL AND THE REPORTED EVENT WAS CONFIRMED. DURING ANALYSIS, THE BLACK POWER LEAD WAS STRIPPED AT THE CONNECTOR END, AND THE BROWN, BATTERY GAUGE, INNER CONDUCTOR WAS CONFIRMED TO BE DAMAGED. THE LOG FILE CAPTURED APPROXIMATELY 4 HOURS OF EVENTS AND A NOTABLE NUMBER OF POWER CABLE DISCONNECT WERE CAPTURED OVER A SHORT PERIOD OF TIME (PER THE TIME STAMP); HOWEVER, PUMP FUNCTION WAS NOT INTERRUPTED. A REVIEW OF THE DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. THIS SITUATION HAS BEEN ADDRESSED THROUGH THE MANUFACTURER'S CORRECTIVE PREVENTATIVE ACTION SYSTEM AND AN URGENT MEDICAL DEVICE CORRECTION NOTICE (2916596/2/10001-C) WAS SENT TO CUSTOMERS. NO FURTHER INFO IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR DEVICE. APPROXIMATELY 4 YEARS POST-IMPLANT, THE PT RECEIVED A POWER CABLE DISCONNECT ALARM WHILE CONNECTED TO EITHER FULLY CHARGED BATTERIES OR A POWER MODULE. THE SUSPECT SYSTEM CONTROLLER WAS EXCHANGED PER THE MANUFACTURER'S INSTRUCTIONS FOR USE AND THE PT REMAINS ONGOING LVAD SUPPORT WITH NO FURTHER ISSUE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER, EU LVAD SYSTEM CONTROLLER DSQ THORATEC CORPORATION 103692 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other