BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 2052767 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-05205
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 28, 2011
    Report Date
    September 19, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A NEW BOSTON SCIENTIFIC RIGHT VENTRICULAR LEAD WAS SUCCESSFULLY IMPLANTED.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS DEVICE WAS LATER EXPLANTED AND RETURNED FOR RELIABILITY ANALYSIS. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED. THE DEVICE WAS THEN SUBJECTED TO A SERIES OF AUTOMATED DIAGNOSTIC TESTS THAT VERIFY THE PERFORMANCE OF THE DEFIBRILLATION, PACING, SENSING, HIGH VOLTAGE SHOCKING AND RECORDING FUNCTIONS OF THE DEVICE. THE DEVICE PERFORMED NORMALLY THROUGHOUT ALL TESTS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DECTECTED GREATER THAN 3000 OHMS ON A NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR LEAD. IN REVIEWING THE THE ARRHYTHMIA LOGBOOK, IT WAS REVEALED THAT THERE WERE NOISE EPISODES WHICH WERE OVERSENSED WITH PACING INHIBITION. HOWEVER, THIS PATIENT HAD AN UNDERLYING RHYTHM IN THE 50-60'S RANGE. THE NOISE WAS ONLY ON THE RATE/SENSE PORTION OF THE LEAD. POCKET MANIPULATION ALSO CREATED AN INCREASE IN IMPEDANCES BY 300 OHMS. NO ADVESRE PATIENT EFFECTS WERE REPORTED. THERE WAS INQUIRY AS TO THE LATITUDE SYSTEM IN RELATION TO THIS EVENT. TECHNICAL SERVICES DISCUSSED TROUBLESHOOTING AND POSSIBLE CAUSES. ONGOING LATITUDE ALERTS CONTINUE FOR THE PACING IMPEDANCE ISSUE.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H170

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR 6947| H170| 1488T| 4193| 7272