BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 3232791 · Received July 18, 2013

    Report

    Report Number
    2124215-2013-11272
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 21, 2013
    Report Date
    July 16, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT LOW SHOCK IMPEDANCE MEASUREMENTS WERE OBSERVED ON THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE AND RIGHT VENTRICULAR (RV) LEAD THROUGH THE REMOTE MONITORING SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE AND LEAD REMAINS IN SERVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED THAT ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS EVEN THE SHOCK IMPEDANCE. ONLY ONE LOW SHOCK IMPEDANCE WAS OUT OF RANGE WHICH TRIGGERED THE RED ALERT. IT WAS CONFIRMED THAT THERE WAS NO LEAD OR DEVICE ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED AND THE PATIENT HAD A NORMAL FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335048 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND P107

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4)| (B)(4)