BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTAK RENEWAL

    MDR report key: 1850249 · Received October 1, 2010

    Report

    Report Number
    2124215-2010-16536
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 1, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. MICROSCOPIC VISUAL INSPECTIONS NOTED NO IRREGULARITIES. ALL SEAL PLUGS INTACT AND ALL SETSCREWS MOVED FREELY. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY 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. LEAD IMPEDANCE TESTING WAS PERFORMED AND ALL MEASUREMENTS WERE WITHIN NORMAL RANGE. AS THE DEVICE MET ALL DESIGN SPECIFICATIONS, ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED NOISE OR OVERSENSING ISSUE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT EXPERIENCED SYNCOPE AND WENT TO THE HOSPITAL. THE PHYSICIAN REVIEWED THE DEVICE ELECTROGRAMS (EGMS) AND NOTED SEVERAL EPISODES OF OVERSENSING DUE TO NOISE. AN X-RAY ANALYSIS OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM REVEALED ANOMALIES ON THE LEAD ELECTRODE. THE REPORT DID NOT DISTINGUISH WHICH LEAD ELECTRODE WAS AFFECTED. THE NEXT DAY, A NEW NON-BOSTON SCIENTIFIC SYSTEM WAS IMPLANTED, AND THIS CRT-D ALONG WITH THE CHRONIC LEADS WERE EXPLANTED WITHOUT FURTHER INCIDENT. THE DEVICE WAS RETURNED FOR ANALYSIS.

    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 Hospitalization| L| R