BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2960537 · Received February 12, 2013

    Report

    Report Number
    2916596-2013-00169
    Event Type
    Injury
    Date Received
    February 12, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER 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). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT WAS EXPERIENCING ALARMS, SPEED DROPS AND POWER CABLE DISCONNECT ALARMS WHEN CONNECTED TO THE SYSTEM MONITOR. THE PATIENT HAD ALSO BEEN OFF COUMADIN MOST OF THE TIME. THE PATIENT'S LOG FILE CONFIRMED LOW SPEED ADVISORIES AND SIGNIFICANT SPEED DROPS. A LOG FILE AND X-RAYS WERE SENT INTO THE MANUFACTURER FOR REVIEW. ON (B)(4) 2013, THE MANUFACTURER'S TECHNICAL SERVICES REPRESENTATIVE PERFORMED A PERCUTANEOUS LEAD DISTAL END REPLACEMENT. ADDITIONAL INFORMATION RECEIVED ADVISED THAT DURING THE PERCUTANEOUS LEAD REPLACEMENT, FLUID WAS DISCOVERED WITHIN THE LEAD. A PUMP EXCHANGE FROM ONE LVAD TO ANOTHER LVAD TOOK PLACE ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60727 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 82281

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention