BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 2173682 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11086
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 20, 2011
    Report Date
    December 18, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    --

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT PRESENTED TO THE CLINIC STATING HE HAD EXPERIENCED TWO EPISODES OF SYNCOPE OVER THE LAST WEEKEND. THE FIRST EPISODE HAPPENED WHILE THE PATIENT WAS WORKING ON HIS MOTORCYCLE AND LASTED FOR OVER FIVE MINUTES. THE SECOND EPISODE OCCURRED WHILE HE WAS SLEEPING AND COULD NOT BE AWAKENED. TECHNICAL SERVICES WAS CONSULTED AND QUESTIONED IF THIS PATIENT MIGHT HAVE SOME FINE VENTRICULAR FIBRILLATION, HOWEVER THERE ARE NO EPISODES IN LOGBOOK THAT WOULD EXPLAIN THE SYNCOPE.

    Description of Event or Problem · 1

    NEW INFORMATION WAS RECEIVED THAT THIS PATIENT'S RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE AND DIVERTED A SHOCK. NOISE WAS VERY MINIMALLY SEEN ON THE ATRIAL LEAD AS WELL. WHEN THE PATIENT WAS IN THE OFFICE FOR A SYNCOPAL EPISODE THE LEAD SENSITIVITY WAS PROGRAMMED TO MOST SENSITIVE AND A MONITOR ONLY ZONE WAS ADDED. ISOMETRICS WERE DONE IN AN ATTEMPT TO RECREATE THE NOISE AND NOISE COULD BE SEEN WHEN THE PATIENT TOOK A DEEP BREATH WHICH SUPPORTS DIAPHRAGMATIC STIMULATION. THE LEAD WAS THEN PROGRAMMED BACK TO NOMINAL TO AVOID ANY ADDITIONAL OVERSENSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H210

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening| O 0185| 4555| 4470| H210