BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIVIAN

    MDR report key: 3211688 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08709
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    May 4, 2013
    Report Date
    May 7, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, INTERROGATION OF THE DEVICE CONFIRMED THE CLINICAL OBSERVATION OF FALLBACK MODE (FUNCTIONALITY LIMITED TO A SINGLE ZONE SHOCK ONLY CONFIGURATION). THERAPY HISTORY AND DIAGNOSTICS WERE NOT AVAILABLE. A REVIEW OF DEVICE MEMORY FOUND THAT THE LAST CAPACITOR REFORMATION WAS PERFORMED IN (B)(6) 2013. THE CAPACITOR REFORMATION WAS SUCCESSFUL AND A CHARGE TIME OF 7.5 SECONDS WAS RECORDED. THE DEVICE APPEARS TO HAVE REVERTED TO FALLBACK MODE ON OR ABOUT (B)(6) 2013. FOUR SOFTWARE RESETS OCCURRED ON (B)(6) 2013. ANY EPISODES THAT OCCURRED AFTER (B)(6) 2013 WERE NOT CAPABLE OF BEING RECORDED BY THE DEVICE DUE TO FALLBACK MODE. THE DEVICE WAS PUT THROUGH MANUAL TESTING THAT VERIFIED THE PERFORMANCE OF PACING, DEFIBRILLATION AND SENSING FUNCTIONS OF THE DEVICE. A TACHYCARDIA EPISODE WAS SIMULATED RESULTING IN NORMAL SENSING AND THERAPY DELIVERY. IT WAS CONCLUDED THAT THE DEVICE MOST LIKELY REVERTED TO FALLBACK MODE FOLLOWING EXPOSURE TO RADIATION THERAPY. THERE WAS NO REASONABLE EVIDENCE TO SUGGEST THAT THE REVERSION TO FALLBACK MODE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE CONTACTED BOSTON SCIENTIFIC'S TECHNICAL SERVICES (TS) TO REPORT THAT THIS PATIENT HAD DIED IN (B)(6) 2013. THE PHYSICIAN REQUESTED THAT THE DEVICE BE INTERROGATED POST-MORTEM. THE FAMILY WANTED TO KNOW THAT THE DEVICE FUNCTIONED APPROPRIATELY AND DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH. UPON INTERROGATION, THE DEVICE DISPLAYED A FALLBACK FAULT CODE WARNING (DEVICE FUNCTION IS PERMANENTLY LIMITED TO VENTRICULAR TACHYCARDIA SINGLE ZONE OPERATION WITH VENTRICULAR PACED SUPPORT). SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD RECEIVED RADIATION THERAPY. THE PHYSICIAN HAD NOT BEEN CONSULTED REGARDING RADIATION TREATMENT AND THE POSSIBLE IMPACT TO THE DEVICE'S OPERATION AND FUNCTIONALITY. THE DEVICE WAS EXPLANTED (POST-MORTEM) AND WAS RECEIVED AT BOSTON SCIENTIFIC'S RETURN PRODUCTS DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308563 LIVIAN IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H220

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR 0175| 4543| H220