BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3950813 · Received June 13, 2014

    Report

    Report Number
    2916596-2014-00986
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ONGOING ON LVAD SUPPORT WITHOUT ANY FURTHER ISSUES REPORTED. A PORTION OF THE PERCUTANEOUS LEAD THAT WAS REMOVED 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 DEVICE ANALYSIS 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 REPORTED RED HEART ALARMS AT HOME. X-RAYS SENT IN AND SHOWED SHIELD BREAKDOWN NEAR THE SYSTEM CONTROLLER END. HOSPITAL MISPLACED ADAPTER TO CONNECT TO SYSTEM MONITOR. UNABLE TO RETRIEVE LOG FILES. A PERCUTANEOUS LEAD REPAIR ASSESSMENT BY THE MANUFACTURER'S TECHNICAL SERVICES MEMBER SHOWED A BROKEN WIRE IN PHASE 2. PHASE INTERRUPTER SHOWED BLACK WIRE WAS BROKEN. A PERCUTANEOUS LEAD REPAIR WAS COMPLETED AND THE PATIENT PLACED BACK ON A GROUNDED CABLE WITH NO ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350692 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 121291

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention