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Company CARDIOMYOPATHY / St. Jude Medical / / Facility clinic WITHIN NORMAL LIMITS / AND DISCHARGED FROM THE HOSPITAL / STABLE POSITION / / IndustryTerm size device / / MedicalCondition arrhythmia / OF A BRADYCARDIA‐TACHYCARDIA SYNDROME / VENA CAVA SUPERIOR SYNDROME / reported pericardial effusion / TO A MYOCARDIAL INFARCTION / SECUNDUM ATRIAL SEPTAL DEFECT / PERICARDIAL EFFUSION / pacemaker CARDIOMYOPATHY / Allergy / COMPLETE HEART BLOCK / AGA/St. Jude Arrhythmia / HEMANGIOMA / MYOCARDIAL INFARCTION / serious injury / Deformation Arrhythmia / sheath Arrhythmia / WITH A RIGHT‐SIDED PLEURAL EFFUSION / MODERATE ANEMIA / code arrhythmia / OF CARDIAC TAMPONADE / Delivery System Arrhythmia / cardiac arrest / ECTOPIC ATRIAL TACHYCARDIA / OF STOMACH UPSET / Valve Dysfunction / ATRIAL SEPTAL DEFECT / SECOND DEGREE HEART BLOCK / / MedicalTreatment Embolization / / Organization Circulatory System Advisory Panel / FDA / / Position IMPLANTING PHYSICIAN / HB / WAS THE PHYSICIAN / PATHOLOGIST / PHYSICIAN / THE IMPLANTING PHYSICIAN / SURGEON / / ProvinceOrState Michigan / /
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Appendix A – FDA Categorization of Events – Sponsor Dispute/Comments