BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3802196 · Received April 24, 2014

    Report

    Report Number
    2916596-2014-00420
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    February 23, 2014
    Report Date
    February 23, 2014
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ONGOING WITH THE IMPLANTED DEVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED. A PORTION OF THE PERCUTANEOUS LEAD THAT WAS REMOVED DURING THE REPAIR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. 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'S PUMP WAS RUNNING BETWEEN 2000 TO 3000 RPM. X-RAYS WERE SENT TO THE MANUFACTURER FOR REVIEW AS THERE WAS EVIDENCE OF DAMAGE AT THE END OF THE BEND RELIEF OF THE EXTERIOR PART OF THE PERCUTANEOUS LEAD. THE PATIENT WAS PUT ON BATTERIES. ON (B)(6) 2014, THE MANUFACTURER'S TECHNICAL SERVICE REPRESENTATIVE CONDUCTED A PERCUTANEOUS LEAD DISTAL END REPLACEMENT ACCORDING TO PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    247923 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 103695 95451

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention