BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2173368 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-12241
    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

    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

    NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM AFTER RECEIVING FIVE INAPPROPRIATE SHOCKS DUE TO NOISE AND OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. UPON EVALUATION THE NOISE WAS ABLE TO BE RECREATED WITH ISOMETRICS AND THE RV LEAD IMPEDANCE MEASUREMENT WAS LESS THAN 200 OHMS, AN INSULATION ISSUE ON THE RV LEAD IS SUSPECTED. TECHNICAL SERVICES ADVISED THE SALES REPRESENTATIVE (SR) TO OBTAIN AN X-RAY TO EVALUTE THE LEAD AND DISCUSS THE SITUATION WITH THE PHYSICIAN. ONE DAY LATER THE DEVICE WAS NOTED TO BE PROGRAMMED WITH TACHYCARDIA THERAPY OFF FOR AN UNKNOWN REASON. AN EMAIL WAS SENT TO THE SR IN AN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION REGARDING THE STATUS OF THE LEAD AND DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE SALES REPRESENTATIVE THAT THE PATIENT IS NOT PACEMAKER DEPENDENT AND THERE WAS NO ASYSTOLE SEEN DURING THE PACING INHIBITION. NO X-RAY WAS TAKEN TO DETERMINE FURTHER LEAD INTEGRITY AND NO INTERVENTION WAS DONE. TACHYCARDIA THERAPY WAS PROGRAMMED OFF IN THE DEVICE, PER THE FAMILIES REQUEST TO UTILIZE THE DEVICE'S PACING FUNCTION ONLY. NO ADDITIONAL 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 N119

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR N119| 0180| 4469| 4555