BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3896041 · Received May 15, 2014

    Report

    Report Number
    2916596-2014-07489
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP IS STILL IN USE SUPPORTING THE PATIENT; HOWEVER, THE REPLACED PORTION OF THE PERCUTANEOUS LEAD WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 HAD THE MANUFACTURER'S TECHNICAL SERVICE GROUP REVIEW THE PATIENT'S LOG FILE AND REVEALED LOW FLOW HAZARD ALARMS PATIENT'S LOG FILE AND REVEALED LOW FLOW HAZARD ALARMS THAT OCCURRED WHILE THE PATIENT WAS CONNECTED TO THE POWER MODULE AND WAS REPORTEDLY WHILE THE PATIENT WAS SLEEPING. THE VAD COORDINATOR REPORTED THAT THE SILICONE OF THE PERCUTANEOUS LEAD WAS SEPARATED AT THE METAL CONNECTOR. AN EVALUATION OF THE PERCUTANEOUS LEAD WAS PERFORMED BY THE MANUFACTURER'S TECHNICAL SERVICE AND DAMAGE THE BLACK WIRE WAS FOUND. A PORTION OF THE PERCUTANEOUS LEAD WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291038 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911 121300

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR