Description of Event or Problem · 0
POST-PROCEDURE TRANSIENT ISCHEMIC ATTACK (TIA). THE SERIOUS ADVERSE EVENT MOST LIKELY OCCURED AS A RESULT OF THE PRESSURE WIRE IN THE LV, NO EVIDENCE OF LBS LEAD PERFORATION. LONG PROCEDURE WITH EPISODE OF EVIDENCE OF LBS LEAD PERFORATION. LONG PROCEDURE WITH EPISODE OF ATRIAL FIBRILLATION TIME ONSET SYMPTOMS: 18:30(90 MINS POST PRCOEDURE) SUDDEN MINIMAL LEVEL OF RESPONSIVENESS WITH FLACCID LEFT HEMIPLEGIA, RIGHT FIXED GAZE CONSCIOUS LEVEL FLUCTUATED BUT PARALYSIS PERSISTED. NO GROSS CN INVOLVEMENT INITALLY - THEN DEVELOPED DEVIATION OF PUPILS ~ 19S0HRS SOME IMPROVEMENT OF L ARM WEAKNESS BUT ONGOING TRANSFERRED TO STROKE UNIT, CT SCAN DONE: NO ACUTE BLEED, NO ACUTE INFARCT DETECTED ASPIRIN 300MG STAT FOLLOWED BY 7SMG CLOPIDOGREL LIFELONG AS PER TIA TX PLAN: 48HR REPEAT CT TO SEE WHETHER THERE HAVE BEEN ANY EVIDENCE OF EVOLVING STROKE (B)(6) 2022 - SYMPTOMS FULLY RESOLVED BY APPROX. 20:17HRS (B)(6) 2022 - PATIENT FEELING WELL INSELF, SYMPTOMS FULLY RECOVERED. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).