BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2173847 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-10728
    Event Type
    Malfunction
    Date Received
    July 24, 2011
    Date of Event
    June 22, 2011
    Report Date
    December 18, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN WHETHER THIS DEVICE WILL BE RETURNED FOR ANALYSIS. SHOULD THE DEVICE BE RETURNED, ANALYSIS WILL BE PERFORMED AND THIS EVENT 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.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE ANALYSIS, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED. A REVISION PROCEDURE WAS PERFORMED. WHEN THE POCKET WAS OPENED, NO OBVIOUS HEADER/CONNECTION ISSUE WAS NOTED AND NO ISSUES WERE ENCOUNTERED LOOSING THE SET SCREWS. THE ATRIAL LEAD WAS DISCONNECTED AND TESTED WITH THE PACING SYSTEM ANALYZER. MEASUREMENTS OBTAINED WERE WITHIN NORMAL LIMITS. A DEVICE WAS MADE TO REPLACE THE ATRIAL LEAD. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. IN ADDITION, A DECISION WAS MADE TO ELECTIVELY REPLACE THIS DEVICE DUE TO THE LENGTH OF IMPLANT. IT COULD NOT BE DETERMINED WHETHER THE INCREASED IMPEDANCE MEASUREMENTS WERE DUE TO A CONNECTION ISSUE OR AN ATRIAL LEAD FRACTURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE AND ATRIAL LEAD PRESENTED TO THE CLINIC AFTER EXPERIENCING SYMPTOMS OF PALPITATIONS AND SHORTNESS OF BREATH. A HOLTER MONITOR REVEALED EPISODES OF HIGH RATE PACING AT THE MAXIMUM TRACKING RATE. DEVICE INTERROGATION REVEALED HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS. IN ADDITION, STORED EPISODES OF ATRIAL TACHYCARDIA RESPONSE WERE NOTED. ISOMETRICS WERE PERFORMED. NOISE AND SIMILAR HIGH OUT OF RANGE IMPEDANCE MEASUREMENTS WERE OBSERVED. IT WAS THOUGHT THERE WAS A LEAD FRACTURE OR CONNECTION ISSUE. A REVISION PROCEDURE WILL BE PERFORMED IN THE NEAR FUTURE. THE DEVICE WAS REPROGRAMMED TO VVIR PACING MODE. NO FURTHER PATIENT SYMPTOMS WERE REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENTLY, THIS DEVICE WAS RECEIVED AT THE POST MARKET QUALITY ASSURANCE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H190

    Patients

    Seq Age Sex Outcome Treatment
    1