BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTAK RENEWAL

    MDR report key: 1952766 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23766
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 6, 2010
    Report Date
    February 22, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    PMA / PMN Number
    P010012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    APPROXIMATELY TWO YEARS LATER, THE DEVICE WAS EXPLANTED FOR NORMAL BATTERY DEPLETION AND REPLACED WITH ANOTHER BOSTON SCIENTIFIC DEVICE. THERE WERE NO ALLEGATIONS OF PRODUCT DEFICIENCY AT THE TIME OF EXPLANT AND NO ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION FROM ANALYSIS, THIS REPORT WILL BE UPDATED. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A REVIEW OF THE DEVICE MEMORY LOG VERIFIED THAT THE SHOCK IMPEDANCE MEASUREMENTS WERE NORMAL OVER THE LAST YEAR PRIOR TO EXPLANT. THE IMPEDANCE VALUES WERE ALSO NORMAL FROM THE PROGRAMMER. 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. ANALYSIS WAS UNABLE TO CONFIRM THE ALLEGATION OF LOW SHOCK IMPEDANCE. THE DEVICE FUNCTIONED NORMALLY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LATITUDE RED ALERT WAS DETECTED DUE TO LOW SHOCK IMPEDANCE MEASUREMENTS. THERE IS NO INFORMATION INDICATING ANY INTERVENTION AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTAK RENEWAL IMPLANTABLE CHF GENERATOR NIK GUIDANT CRM CLONMEL IRELAND H217

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR 4136| H217| 4543| 4555| 0185