BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2772205 · Received October 2, 2012

    Report

    Report Number
    2916596-2012-00924
    Event Type
    Malfunction
    Date Received
    October 2, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 6, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PORTION OF THE PERCUTANEOUS LEAD THAT WAS REMOVED WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT AFTER 15 MONTHS OF SUPPORT, THE PT WAS EXPERIENCING RED HEART ALARMS WHILE CONNECTED TO THE POWER MODULE (TETHERED SUPPORT). A REVIEW OF THE PT'S HISTORICAL DATA SHOWED THAT THE SYSTEM CONTROLLER HAD RECORDED PUMP STOPS AND REDUCTIONS IN PUMP SPEED. THE PT WAS REPORTEDLY ASYMPTOMATIC DURING THESE EVENTS. THE PT WAS ADMITTED FOR FURTHER EVAL OF THE INTERNAL AND EXTERNAL PORTIONS PERCUTANEOUS LEAD. THE MFR'S TECHNICAL SERVICES TEAM MEMBER EVALUATED THE PT'S PERCUTANEOUS LEAD AND IDENTIFIED A BROKEN INNER WIRE ON THE EXTERNAL PORTION OF THE PERCUTANEOUS LEAD. AS A RESULT, THE COMPROMISED SECTION OF THE LEAD WAS REPLACED AND, POST-REPAIR, THE PT WAS SUCCESSFULLY SUPPORTED ON THE POWER MODULE WITHOUT ANY FURTHER ALARMS. THE PT WAS DISCHARGED HOME AND REMAINS ONGOING ON LVAD SUPPORT WITHOUT ANY FURTHER ISSUES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 105144

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other