Description of Event or Problem · 0
ICD DATA FOR DEVICE DETECTED VT EPISODES AND DEVICE TREATED VT EPISODES WERE COLLECTED FOR 6-MONTHS PRE- AND POSTABLATION. RESULTS: SUBSTRATE ANALYSIS DEMONSTRATED REDUCTIONS IN THE BORDERZONE AREA OF 4.4 CM2 (P = 0.026) AND LATE POTENTIAL AREA OF 3.5 CM2 (P = 0.0449) POST-ABLATION, WITH REDUCTIONS IN THE MEAN BIPOLAR AND UNIPOLAR VOLTAGES OF THE ABLATION TARGET AREAS (0.14 MV (P = 0.0007); 0.59 MV (P = 0.0072) RESPECTIVELY). COMPLETE PROCEDURAL SUCCESS WAS ACHIEVED IN 9 PROCEDURES. POST-ABLATION VT INDUCIBILITY TESTING WAS NOT PERFORMED IN 1 PROCEDURE DUE TO A STEAM POP COMPLICATION RESULTING IN REQUIRING DRAINAGE. MEAN FOLLOW-UP OF 214 ? 33 DAYS REVEALED AN 88% (N = 266 MEDIAN 16 [IQR 3?57] TO N = 33 MEDIAN 0; P = 0.0164) AND 77% REDUCTION IN ICD THERAPIES (N = 128 MEDIAN 5 [IQR 2?15] TO N = 30 MEDIAN 0; P = 0.0181). PERICARDIAL TAMPONADE OCCURRED DUE TO A STEAM POP AFTER 48 MIN OF ABLATION REQUIRING. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).