BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3042927 · Received April 4, 2013

    Report

    Report Number
    2916596-2013-00378
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT CONTINUES ON LVAD SUPPORT WITH NO FURTHER ISSUE REPORTED. 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 MFR'S INVESTIGATION 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 20 MONTHS OF SUPPORT ON THE LVAD, THE PT PRESENTED TO THE HOSPITAL FOR AN ESOPHAGOGASTRODUODENOSCOPY (EGD) AND LOW FLOW ALARMS WERE NOTED WHILE CONNECTED TO THE POWER MODULE (TETHERED SUPPORT). NO ALARMS WERE REPORTEDLY OBSERVED WHILE THE PT WAS ON BATTERY POWER. WHILE IN THE HOSPITAL, IT WAS NOTED THAT IN ADDITION TO THE LOW FLOW ALARMS WHILE ON TETHERED SUPPORT, THE PUMP WAS OPERATING BELOW THE SET SPEED. THE VAD COORDINATOR ATTEMPTED TO TROUBLESHOOT BY EXCHANGING THE PT'S PT CABLE AND USING A NEW POWER MODULE, BUT THE DROP IN PUMP SPEED AND LOW FLOW ALARMS DID NOT RESOLVE. THE PT WAS PLACED ON BATTERY POWER AWAITING FURTHER EVAL OF THE PERCUTANEOUS LEAD. X-RAYS OF THE PERCUTANEOUS LEAD SHOWED POSSIBLE DAMAGE TO THE DISTAL END OF THE BEND RELIEF. A REPAIR/REPLACEMENT OF THE EXTERNAL PORTION (DISTAL END) OF THE LEAD WAS SUBSEQUENTLY PERFORMED BY THE MFR'S TECHNICAL SERVICES TEAM MEMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139200 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911 105638

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention