BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 1960302 · Received December 15, 2010

    Report

    Report Number
    2916596-2010-00343
    Event Type
    Malfunction
    Date Received
    December 15, 2010
    Date of Event
    August 20, 2010
    Report Date
    November 19, 2010
    Manufacturer
    THORATEC CORP
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OF ALARMS WHILE CONNECTED TO THE POWER MODULE WAS CONFIRMED DURING ANALYSIS. THE BLACK CABLE WAS STRIPPED AT THE CONNECTOR END, AND THE (BROWN) BATTERY GAUGE INNER CONDUCTOR WAS CONFIRMED TO BE BROKEN. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS SYSTEM CONTROLLER SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. THIS SITUATION IS BEING ADDRESSED THROUGH THE MANUFACTURER'S CORRECTIVE/PREVENTATIVE ACTION SYSTEM AND AN URGENT MEDICAL DEVICE CORRECTION NOTICE (29165969/2/10001-C) WAS SENT TO CUSTOMERS. NO FURTHER INFORMATION 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 ASSIST DEVICE. THE VAD COORDINATOR REPORTED THAT THE PT RECEIVED ALARMS WHILE CONNECTED TO THE POWER 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 30 YR Other