BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3102322 · Received April 30, 2013

    Report

    Report Number
    2916596-2013-00502
    Event Type
    Malfunction
    Date Received
    April 30, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT CONTINUES ON LVAD SUPPORT WITH NO FURTHER ISSUES REPORTED. NO FURTHER INFORMATION 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 PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT THE PATIENT RECEIVED ALARMS WHEN CONNECTED TO THE POWER MODULE. AN UNGROUNDED CABLE WAS REQUESTED AND SENT TO THE PATIENT. THE EXTERNAL PORTION OF THE PERCUTANEOUS LEAD DOES NOT HAVE ANY SUSPECTED AREAS OF CONCERN. ADDITIONAL INFORMATION SUBMITTED TO THE MANUFACTURER INDICATED THAT THE LOG FILE CONFIRMS PUMP STOPPAGE. THE X-RAY PROVIDED SHOWS AN AREA OF CONCERN ON THE DISTAL END OF THE EXTERNAL PORTION OF THE PERCUTANEOUS LEAD CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188745 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 96849

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other