BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 1930099 · Received November 18, 2010

    Report

    Report Number
    2916596-2010-00302
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    THORATEC CORP
    Product Code
    DSQ
    Removal / Correction Number
    29165969/2/10001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVAL. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT THE PT WAS EXPERIENCING UNUSUAL ALARMS AND IN ADDITION, DURING THE USUAL CLINIC VISIT, THE EVAL OF THE RECORDED READINGS SHOWED A PUMP STOP. WAVEFORMS AND LOG FILES HAVE BEEN SENT TO THE MANUFACTURER FOR ANALYSIS. IT WAS RECOMMENDED BY THE MANUFACTURER'S TECHNICAL SERVICE PERSON TO EXCHANGE THE SYSTEM CONTROLLER WITH ANOTHER SYSTEM CONTROLLER. NO FURTHER PROBLEMS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II SYSTEM CONTROLLER LVAD SYSTEM CONTROLLER DSQ THORATEC CORP 103696 89967

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other