BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2173214 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10745
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR CAUSED A LATITUDE RED ALERT TO BE DECLARED DUE TO LOW OUT OF RANGE SHOCK IMPEDANCES. THE RIGHT VENTRICULAR DEFIBRILLATION LEAD IS A COMPETITOR LEAD. A CHEST X-RAY WAS CONFIRMED AND REVEALED A FRACTURED LEAD COIL. THE DEVICE WAS REPROGRAMMED TO RV-CAN SHOCK VECTOR. HOWEVER, DUE TO THE LOW SHOCK IMPEDANCES AND DAMAGED LEAD, THE POSSIBILITY FOR A SHORTED LEAD CONDITION WAS PRESENT WHICH COULD LEAD TO INTERNAL CIRCUITRY DAMAGE TO THE DEVICE AND THUS PREVENT THE DEVICE FROM EFFECTIVELY DELIVERING SHOCK THERAPY. A COMPETITOR LEAD REVISION MAY BE PERFORMED IN THE NEAR FUTURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P107

    Patients

    Seq Age Sex Outcome Treatment
    1 Other