BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COGNIS

    MDR report key: 2913270 · Received January 14, 2013

    Report

    Report Number
    2124215-2012-17080
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NIK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AVAILABLE INFORMATION INDICATES THE DEVICE AND RV LEAD REMAIN IMPLANTED WITH NO FURTHER ISSUES REPORTED. AN AMENDED REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) IMPLANT PROCEDURE, THE PATIENT BECAME ASYSTOLIC. EXTERNAL PACING WAS STARTED AND WAS NOTED TO BE INTERMITTENT. A RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WAS IMPLANTED AND CONNECTED TO THE PACING SYSTEM ANALYZER (PSA). IT WAS REPORTED THAT THE PATIENT HAD A LBBB, AND THE PHYSICIAN BELIEVED THE WIRE FROM THE COMPETITIVE INTRODUCER KIT DAMAGED THE RBB. THE PATIENT BECAME PACEMAKER DEPENDENT, AND NO INTRINSIC RHYTHM WAS OBSERVED THROUGHOUT THE PROCEDURE. A RIGHT ATRIAL (RA) LEAD WAS SUCCESSFULLY IMPLANTED. DURING PLACEMENT OF THE LEFT VENTRICULAR (LV) LEAD, A SMALLER THAN EXPECTED BRANCH WAS ACCESSED AND WHEN THE LEAD WAS PLACED, PACING THRESHOLD MEASUREMENTS WERE HIGH. THE LEAD WAS REPOSITIONED SEVERAL TIMES, BUT GOOD THRESHOLDS COULD NOT BE OBTAINED. A NEW LV LEAD MODEL WAS ATTEMPTED, BUT COULD NOT BE PLACED. DIFFICULTY WAS ENCOUNTERED WITH THE INNER CATHETER, AS THE VALVE HAD GOTTEN STUCK. THE LV LEAD WAS ABORTED, AND THE CRT-D WAS CONNECTED TO THE RA AND RV LEADS. EXTERNAL PACING WAS PROVIDED TO THE PATIENT WHEN CONNECTING THE RV LEAD TO THE DEVICE. WHEN THE LEAD WAS INSERTED, INTERMITTENT PACING WITH LONG PAUSES WAS OBSERVED. NO NOISE WAS NOTED ON THE RV ELECTROGRAM, BUT IT APPEARED THERE WAS OVERSENSING OF SOMETHING. ADDITIONALLY, LV MARKERS WERE NOTED ON THE EGMS. A TECHNICAL SERVICES CONSULTANT DISCUSSED PROGRAMMING STEPS TO RESOLVE THE LV MARKERS, AND PROVIDED TROUBLESHOOTING FOR THE PAUSES IN PACING. IT WAS REPORTED THAT DURING THE OVERSENSING, THE DEVICE WAS NOT IN THE POCKET; ONCE THE DEVICE WAS PLACED IN THE POCKET, THE OVERSENSING WAS RESOLVED. FINAL TESTING SHOWED NORMAL LEAD DIAGNOSTICS ON THE RA AND RV LEADS. THE POST-OPERATIVE CHECK ALSO FOUND NORMAL LEAD MEASUREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20721 COGNIS IMPLANTABLE CHF PULSE GENERATOR NIK GUIDANT CRM CLONMEL IRELAND N107

    Patients

    Seq Age Sex Outcome Treatment
    1