BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3093721 · Received May 1, 2013

    Report

    Report Number
    2916596-2013-00528
    Event Type
    Injury
    Date Received
    May 1, 2013
    Date of Event
    April 6, 2013
    Report Date
    April 6, 2013
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IN USE SUPPORTING THE PT. 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PREVIOUS DAY THE PT EXPERIENCED A RED HEART ALARM WHILE AT HOME, WAS BROUGHT INTO THE HOSPITAL AND HIS SYSTEM CONTROLLER AND POWER MODULE PT CABLE WERE EXCHANGED. THE PT CALLED THE VAD COORDINATOR THE FOLLOWING MORNING TO STATE THAT HE EXPERIENCED ANOTHER RED HEART ALARM WHILE CONNECTED TO THE POWER MODULE. THE ALARM DID NOT OCCUR WHEN THE PT WAS ON BATTERY POWER. THE PT FELT FINE AND DID NOT HAVE ANY SYMPTOMS DURING THE EVENTS. THE LOG FILE OF THE PT'S ORIGINAL SYSTEM CONTROLLER THAT WAS EXCHANGED WAS REVIEWED BY THE MANUFACTURER'S TECHNICAL SERVICE REPRESENTATIVE, AND PUMP STOPS AND A DATA PATTERN INDICATIVE OF A POSSIBLE PERCUTANEOUS LEAD ISSUE WERE NOTED. X-RAYS WERE TAKEN AND WERE UNREMARKABLE. THE VAD COORDINATOR NOTICED A SECTION OF THE PERCUTANEOUS LEAD A FEW INCHES FROM THE SYSTEM CONTROLLER CONNECTION THAT FELT INCONSISTENT. THE ISSUE COULD NOT BE TROUBLESHOT DUE TO THE PUMP STOPPING AS SOON AS THE PT WAS CONNECTED TO THE POWER MODULE. IT WAS REPORTED THAT THE PT IS UP FOR A TRANSPLANT AND THEY WOULD LIKE TO AVOID A PUMP EXCHANGE. THE PT WAS ADMITTED INTO THE HOSPITAL AND WAS ON BATTERY POWER UNTIL HE RECEIVED AN UNGROUNDED PT CABLE. NINE DAYS LATER IT WAS REPORTED THAT THE PT WAS PLACED ON THE UNGROUNDED PT CABLE AND MONITORED OVERNIGHT. NO ALARMS OR ISSUES OCCURRED AND THE PT WAS DISCHARGED. THE PT REMAINS ONGOING WITH THE UNGROUNDED CABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190383 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911 115859

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention