Description of Event or Problem · 0
DURING A CAVO-TRICUSPID ISTHMUS ABLATION FOR RIGHT ATRIAL FLUTTER PROCEDURE, A NOISE ISSUE WAS NOTED ON THE NON-ABBOTT (GE) EGMS RESULTING IN A CLINICALLY SIGNIFICANT DELAY. THERE WAS NO NOISE ON THE ENSITE X ECGS OR EGMS, HOWEVER THERE WAS NOISE NOTED ON THE NON-ABBOTT (GE) CARDIOLAB EGMS. DESPITE SEEING CLEAN ENSITE X EGMS, THE CATHETERS COULD NOT BE VISUALIZED IN NAVX MODE. IN AN ATTEMPT TO TROUBLESHOOT, THE CASE WAS CLOSED ON THE ENSITE X SYSTEM AND A NEW CASE WAS REATTEMPTED, HOWEVER THIS RESULTED IN FLASHING ORANGE LIGHT ON THE AMPLIFIER. POWER CYCLING DID NOT RESOLVE THE ISSUE. TO RESOLVE THE NOISE ISSUE, IT WAS DETERMINED THAT THE NON-ABBOTT (GE) CARDIOLAB ACTIVE RIGHT LEG DRIVE HAD NOT BEEN SWITCHED TO PASSIVE IN THE SYSTEM CONFIGURATIONS. THE NON-ABBOTT (GE) RIGHT LEG LEAD WAS REMOVED FROM THE ENSITE X ECG OUTPUT MODULE AND CONNECTED DIRECTLY TO THE PATIENT. THE PROCEDURE WAS COMPLETED; HOWEVER, THE PATIENT WAS ANESTHETIZED FOR A CLINICALLY SIGNIFICANT LONGER PERIOD THAN NORMAL AND WAS CONSIDERED AN ADVERSE CONSEQUENCE BY THE PHYSICIAN. "THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)".