Description of Event or Problem · 0
NOTIFICATION OF AN ELECTRODE REVISION: PATIENT ID (INTERNAL):(B)(6) (BORN ON:(B)(6)1953). DATE OF SURGERY: (B)(6) 2023. CUT-SUTURE TIME: 09:27-12: (REVISION OF THE ELECTRODE IMPEDANCE RISE (LV (LEFT VENTRICULAR) AND RA (RIGHT ATRIAL) ELECTRODES)). OUTCOME FROM OP: QUOTE FROM THE OP (OPERATIVE) REPORT ON THE PROCEDURE: NOW THE RA ELECTRODE IS SHOWN UP TO THE SLEEVE. THIS IS LOOSENED AND A ¿HARD STYLET¿ IS INSERTED INTO THE ELECTRODE. THE INTRACARDIAC SCREW IS SCREWED BACK. THE ELECTRODE IS MOBILIZED. SUBSEQUENTLY, TO SECURE THE VASCULAR ACCESS, A SNARE CATHETER IS PRESENTED. HOWEVER, EVEN AFTER SEVERAL ATTEMPTS, IT IS NOT POSSIBLE TO CAPTURE THE ELECTRODE IN THE AREA OF THE RIGHT ATRIUM (A.E. INTUSSUSCEPTION SHEATH). PHLEBOGRAPHY. THERE IS A STENOSED V. ANONYMA. SUBSEQUENT PUNCTURE OF THE SUBCLAVIAN VEIN. HOWEVER, A LOCK WIRE CANNOT BE ADVANCED VIA THE STENOSIS. SWITCH TO A TERUMO WIRE, WITH WHICH THE STENOSIS CAN BE PASSED. NEW IMPLANTATION OF AN RA ELECTRODE IN THE RAA WITH GOOD MEASURED VALUES OF THE VASCULAR ACCESS CREATED IN THIS WAY. PULL OF THE OLD RA ELECTRODE. IN THIS CASE, HOWEVER, THE LV ELECTRODE DISLOCATES DUE TO ADHESION. RE-PUNCTURE OF THE SUBCLAVIAN VEIN. PRESENTATION OF A TERUMO WIRE AND SECURING THE ACCESS TO THE VESSEL. INTRODUCE A CONTROLLABLE CS LOCK. ABOUT THIS PROBING OF THE CS, IT SHOWS THE ORIGINAL POSTEROLATERAL VEIN SUB TOTALLY OCCLUDED. BY MEANS OF DIFFERENT PTCA (PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY) WIRES, IT IS FINALLY POSSIBLE TO OVER DEDICATE THE STENOSIS AND TO PRESENT A NEW QUADRIPOLAR LV ELECTRODE OVER THE WIRE. SATISFACTORY MEASURED VALUES. SUBSEQUENTLY, HOWEVER, THE RA ELECTRODE IS DISLOCATED AGAIN. REPOSITIONING OF THE RA ELECTRODE AT SATISFACTORY MEASURED VALUES. BOTH ELECTRODES ARE SECURED WITH 2 NONABSORBABLE THREADS OVER THE SLEEVE. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).