BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVIAN

    MDR report key: 2913330 · Received January 14, 2013

    Report

    Report Number
    2124215-2012-17610
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 15, 2012
    Report Date
    October 15, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND ANOTHER MANUFACTURE'S RIGHT VENTRICULAR LEAD DISPLAYED HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. THE LOCAL FIELD REPRESENTATIVE REACHED OUT TO THE PATIENT'S CLINIC BUT HAD NOT RECEIVED ANY ADDITIONAL INFORMATION REGARDING THIS EVENT. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE REMAINS IN SERVICE.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATED THAT AN ADDITIONAL LATITUDE ALERT WAS DELIVERED FOR A HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. UPON REVIEW OF LATITUDE, IT WAS NOTED THAT THE PATIENT HAD A VENTRICULAR TACHYCARDIA (VT) EPISODE FOR WHICH SHOCK THERAPY WAS DELIVERED. THE SHOCK THERAPY WAS NOT SUCCESSFUL IN CONVERTING THE PATIENT'S VT AND THE PATIENT HAD APPEARED TO CONVERT ON THEIR OWN. THE LOCAL BOSTON SCIENTIFIC FIELD REPRESENTATIVE WAS NOT AWARE OF ANY FURTHER INFORMATION. THE DEVICE REMAINS IN SERVICE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20198 LIVIAN IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H220

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR 6947| H220| (B)(4)| 4543| MISMATCH| 7231| 4554| 4549