BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3960056 · Received May 29, 2014

    Report

    Report Number
    2916596-2014-00817
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 24, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ON GOING WITH THE IMPLANTED DEVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    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 A RED HEART ALARM WAS SUSPECTED. A LOG FIE WAS SENT INTO THE MANUFACTURER FOR REVIEW. THE LOG FILE WAS SENT INTO THE MANUFACTURER FOR REVIEW. THE LOG FILE WAS SENT INTO THE MANUFACTURER WHICH DID NOT SHOW ANY AREAS OF SIGNIFICANT DAMAGE. THE SYSTEM CONTROLLER WAS EXCHANGED AND A RED HEART ALARM WAS EXPERIENCED AGAIN. THE MANUFACTURER'S TECHNICAL SERVICE REPRESENTATIVE PERFORMED A CONTINUITY TEST WHICH DID NOT SHOW ANY BROKEN WIRES. AN EXTERNAL PERCUTANEOUS LEAD DISTAL END REPLACEMENT AS CLOSE TO THE EXIT SITE AS POSSIBLE WAS PERFORMED ACCORDING TO PROCEDURE. THE PATIENT WAS CONNECTED BACK TO THE PATIENT CABLE AND HAD NO ALARMS UNTIL HE TRIED TO PUT ON HIS SHIRT, THEN EXPERIENCED A PUMP DISCONNECT ALARM. AN INTERNAL ISSUE IS SUSPECTED. AN UNDERGROUND PATIENT CABLE WAS REQUESTED AND SHIPPED TO THE HOSPITAL SO PATIENT COULD GO HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315690 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 10341

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention