Shockless Implant Evaluation | NCT00800384

Name	Class
Guidant Corporation	INDUSTRY

Label	Type	Description	Intervention Names
1	Experimental	ICD implant without defibrillation testing	Device: Implantable defibrillator
2	Active Comparator	ICD implant with defibrillation testing	Device: Implantable defibrillator

Name	Type	Description	Arm Group Labels	Other Names
Implantable defibrillator	Device	Implantable defibrillator to detect and terminate ventricular arrhythmias	1 2

Measure	Description	Time Frame
First Occurrence of the Composite of Failed First Appropriate Clinical Shock From the Implantable Cardioverter Defibrillator (ICD) or Arrhythmic Death	The number of patients having experienced either an appropriate inefficient shock and/or arrhythmic death during the follow-up time frame of 3.1 years is compared between both groups.	Mean follow-up of 3.1 years

Measure	Description	Time Frame
Perioperative Complication Rate	A predefined set of expected complications attributed to defibrillation testing during implant procedure was analyzed in both groups.	30 days

Name	Affiliation	Role
Jeff Healey, MD	Population Health Research Institute Canada	Principal Investigator
Stuart Connolly, MD	Population Health Research Institute Canada	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
The Royal Melbourne Hospital		Melbourne		3050	Australia
Landesklinikum St. Poelten

PubMed Identifier	Type	Citation	Retractions
29157723	Derived	Vamos M, Healey JS, Wang J, Connolly SJ, Mabo P, Van Erven L, Kautzner J, Glikson M, Neuzner J, O'Hara G, Vinolas X, Gadler F, Hohnloser SH. Implantable cardioverter-defibrillator therapy in hypertrophic cardiomyopathy: A SIMPLE substudy. Heart Rhythm. 2018 Mar;15(3):386-392. doi: 10.1016/j.hrthm.2017.11.020. Epub 2017 Nov 20.
26569461

ID	Title	Description
FG000	ICD Implant Without Defibrillation Testing	Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
FG001	ICD Implant With Defibrillation Testing

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
PG System	Cardiac disorders	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0011 events1 affected1,253 at risk
Unable to capture - RV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
Unable to convert - Defibrillation	Cardiac disorders	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG00111 events10 affected1,253 at risk
Elevated DFT - Defibrillation	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0012 events2 affected1,253 at risk
PG system - Therapy	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0011 events1 affected1,253 at risk
Inappropriate tachy therapy - SVT	Cardiac disorders	BSC coding list	Systematic Assessment	EG00027 events25 affected1,247 at risk EG00130 events25 affected1,253 at risk
Inappropriate tachy therapy - NSR	Cardiac disorders	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0013 events3 affected1,253 at risk
Inappropriate tachy therapy - Noise	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0012 events2 affected1,253 at risk
Inappropriate tachy therapy - Other	Cardiac disorders	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0010 events0 affected1,253 at risk
Early ERI - Random component failure	Cardiac disorders	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0010 events0 affected1,253 at risk
Early ERI - Consistent with device programming	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
Early ERI - Premature declaration	Cardiac disorders	BSC coding list	Systematic Assessment	EG0003 events3 affected1,247 at risk EG0014 events4 affected1,253 at risk
Pacemaker-mediated tachycardia	Cardiac disorders	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0010 events0 affected1,253 at risk
PG System - Patient related	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
Erosion	Skin and subcutaneous tissue disorders	BSC coding list	Systematic Assessment	EG0005 events5 affected1,247 at risk EG0017 events6 affected1,253 at risk
PG system - Infection (> 30 days post implant)	Infections and infestations	BSC coding list	Systematic Assessment	EG00029 events24 affected1,247 at risk EG00123 events21 affected1,253 at risk
Psychological effect due to device therapy	Psychiatric disorders	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0011 events1 affected1,253 at risk
Seroma - Pocket (> 30 days post- implant)	Infections and infestations	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
Migration	Skin and subcutaneous tissue disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0013 events3 affected1,253 at risk
Post-surgical wound discomfort	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0007 events7 affected1,247 at risk EG0012 events2 affected1,253 at risk
Post-surgical pocket hemorrhage	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0014 events4 affected1,253 at risk
Post-surgical infection (<= 30 days post-implant)	Infections and infestations	BSC coding list	Systematic Assessment	EG00013 events11 affected1,247 at risk EG00110 events10 affected1,253 at risk
Adverse reaction - General	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0015 events5 affected1,253 at risk
Adverse reaction - Respiratory	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0016 events6 affected1,253 at risk
Adverse reaction - Hypotension	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0012 events2 affected1,253 at risk
Hemodynamic instability - DFT testing	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
Inadvertent VT/VF	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0015 events5 affected1,253 at risk
Inadvertent SVT	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0013 events3 affected1,253 at risk
Chest pain	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0010 events0 affected1,253 at risk
Hemorrhage	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0015 events5 affected1,253 at risk
Physical trauma	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0012 events2 affected1,253 at risk
Hematoma - Pocket (<=30 days post-implant)	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG00024 events23 affected1,247 at risk EG00131 events31 affected1,253 at risk
Seroma - Pocket (<=30 days post-implant)	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
Thromboembolic events	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0007 events6 affected1,247 at risk EG00110 events10 affected1,253 at risk
Other - PG system - Procedure	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0012 events2 affected1,253 at risk
Undersensing - RA	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
Unable to capture - RA	Cardiac disorders	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0010 events0 affected1,253 at risk
Elevated threshold - RA	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0012 events2 affected1,253 at risk
Conductor coil fracture - RA	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0010 events0 affected1,253 at risk
Dislodgment - Unable to capture - RA	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0014 events3 affected1,253 at risk
Dislodgment - Extracardiac stimulation- RA	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
Dislodgment - Multiple signs - RA	Cardiac disorders	BSC coding list	Systematic Assessment	EG0004 events4 affected1,247 at risk EG0011 events1 affected1,253 at risk
Dislodgment - No reported signs - RA	Cardiac disorders	BSC coding list	Systematic Assessment	EG0008 events8 affected1,247 at risk EG0019 events8 affected1,253 at risk
Other - Lead	Cardiac disorders	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0013 events3 affected1,253 at risk
RV - unspecific	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0011 events1 affected1,253 at risk
Oversensing - RV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0010 events0 affected1,253 at risk
Unable to capture - RV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0007 events7 affected1,247 at risk EG0011 events1 affected1,253 at risk
Elevated threshold - RV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0007 events7 affected1,247 at risk EG0016 events6 affected1,253 at risk
Conductor coil fracture - RV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
Insulation breach - RV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0014 events4 affected1,253 at risk
Electrode damaged - RV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0011 events1 affected1,253 at risk
Myocardial perforation post- implant - RV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
Impedance < 300 ohms - RV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
Impedance > 2000 ohms - RV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
Dislodgment - Unable to capture RV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
Dislodgment - Elevated threshold -RV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0007 events7 affected1,247 at risk EG0012 events2 affected1,253 at risk
Dislodgment - Oversensing - RV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0010 events0 affected1,253 at risk
Dislodgment - Multiple signs - RV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0003 events3 affected1,247 at risk EG0013 events3 affected1,253 at risk
Dislodgment - No reported signs - RV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0007 events7 affected1,247 at risk EG0019 events8 affected1,253 at risk
Unable to capture - LV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0013 events3 affected1,253 at risk
Elevated threshold - LV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0011 events1 affected1,253 at risk
Extracardiac stimulation - LV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0004 events4 affected1,247 at risk EG0014 events4 affected1,253 at risk
Electrode damaged - LV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
Dislodgment - Unable to capture - LV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0011 events1 affected1,253 at risk
Dislodgment - Elevated threshold - LV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0010 events0 affected1,253 at risk
Dislodgment - Extracardiac stimulation- LV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0012 events2 affected1,253 at risk
Dislodgment - Multiple signs - LV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0011 events1 affected1,253 at risk
Dislodgment - No reported signs -LV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0006 events5 affected1,247 at risk EG0014 events4 affected1,253 at risk
Oversensing - Defibrillation lead	Cardiac disorders	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0013 events3 affected1,253 at risk
Undersensing - Defibrillation lead	Cardiac disorders	BSC coding list	Systematic Assessment	EG0003 events3 affected1,247 at risk EG0013 events3 affected1,253 at risk
Elevated DFT - Defibrillation lead	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0011 events1 affected1,253 at risk
Puncture site hematoma - Procedure	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
Pneumothorax - Procedure	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG00020 events19 affected1,247 at risk EG00111 events11 affected1,253 at risk
Renal failure due to contrast media - Procedure	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0010 events0 affected1,253 at risk
Pleural effusion - Procedure	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0011 events1 affected1,253 at risk
Hemothorax - Procedure	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
Coronary venous dissection	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0013 events3 affected1,253 at risk
Myocardial perforation with tamponade	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0012 events2 affected1,253 at risk
AV block (transient) - Procedure	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
Pericardial effusion	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0008 events7 affected1,247 at risk EG0013 events3 affected1,253 at risk
Other - Lead - Procedure	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG00018 events18 affected1,247 at risk EG00118 events18 affected1,253 at risk
Patient CONDITION Cardiovascular	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0010 events0 affected1,253 at risk
Tachycardia - unspecific	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
Bradyarrhythmias - unspecific	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
1st degree AV block	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0011 events1 affected1,253 at risk
3rd degree AV block	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0012 events2 affected1,253 at risk
Sinus bradycardia	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0013 events3 affected1,253 at risk
Pulseless electrical activity (PEA)	Cardiac disorders	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0015 events5 affected1,253 at risk
Ventricular tachyarrhythmias - unspecified	Cardiac disorders	BSC coding list	Systematic Assessment	EG0006 events6 affected1,247 at risk EG0018 events7 affected1,253 at risk
Ventricular fibrillation (VF)	Cardiac disorders	BSC coding list	Systematic Assessment	EG00013 events13 affected1,247 at risk EG0018 events7 affected1,253 at risk
Ventricular tachycardia (VT)	Cardiac disorders	BSC coding list	Systematic Assessment	EG00065 events49 affected1,247 at risk EG00157 events38 affected1,253 at risk
Electrical Storm	Cardiac disorders	BSC coding list	Systematic Assessment	EG00015 events15 affected1,247 at risk EG00115 events13 affected1,253 at risk
Nonsustained ventricular tachycardia (NSVT)	Cardiac disorders	BSC coding list	Systematic Assessment	EG0005 events5 affected1,247 at risk EG0012 events2 affected1,253 at risk
Ventricular flutter	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
Atrial Tachyarrhythmias - unspecific	Cardiac disorders	BSC coding list	Systematic Assessment	EG0006 events6 affected1,247 at risk EG0012 events2 affected1,253 at risk
Atrial fibrillation (AF)	Cardiac disorders	BSC coding list	Systematic Assessment	EG00048 events42 affected1,247 at risk EG00165 events49 affected1,253 at risk
Atrial flutter	Cardiac disorders	BSC coding list	Systematic Assessment	EG00017 events13 affected1,247 at risk EG00117 events17 affected1,253 at risk
Other SVT (eg AVRT, AVNRT, EAT)	Cardiac disorders	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0018 events7 affected1,253 at risk
Atypical Atrial Flutter	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
Premature ventricular contractions (PVC)	Cardiac disorders	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0014 events4 affected1,253 at risk
Syncope - Heart failure	Cardiac disorders	BSC coding list	Systematic Assessment	EG0003 events3 affected1,247 at risk EG0010 events0 affected1,253 at risk
Dizziness - Heart failure	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0010 events0 affected1,253 at risk
Chest pain - Heart failure	Cardiac disorders	BSC coding list	Systematic Assessment	EG0007 events6 affected1,247 at risk EG0012 events2 affected1,253 at risk
Dyspnea - Heart failure	Cardiac disorders	BSC coding list	Systematic Assessment	EG00050 events42 affected1,247 at risk EG00150 events41 affected1,253 at risk
Peripheral edema - Heart failure	Cardiac disorders	BSC coding list	Systematic Assessment	EG00012 events7 affected1,247 at risk EG0015 events5 affected1,253 at risk
Pulmonary edema - Heart failure	Respiratory, thoracic and mediastinal disorders	BSC coding list	Systematic Assessment	EG00026 events23 affected1,247 at risk EG00114 events12 affected1,253 at risk
Fatigue - Heart failure	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0011 events1 affected1,253 at risk
Renal insufficiency - Heart failure	Renal and urinary disorders	BSC coding list	Systematic Assessment	EG00012 events9 affected1,247 at risk EG0016 events4 affected1,253 at risk
Dehydration - Heart failure	Cardiac disorders	BSC coding list	Systematic Assessment	EG0004 events4 affected1,247 at risk EG0014 events4 affected1,253 at risk
Gastrointestinal - Heart failure	Gastrointestinal disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0011 events1 affected1,253 at risk
Heart failure symptoms - Unspecified	Cardiac disorders	BSC coding list	Systematic Assessment	EG00045 events37 affected1,247 at risk EG00162 events42 affected1,253 at risk
Multiple heart failure symptoms	Cardiac disorders	BSC coding list	Systematic Assessment	EG000212 events145 affected1,247 at risk EG001202 events138 affected1,253 at risk
Hypertension - Heart failure	Cardiac disorders	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0011 events1 affected1,253 at risk
Other- Heart failure patient condition - Cardiovascular	Cardiac disorders	BSC coding list	Systematic Assessment	EG0007 events7 affected1,247 at risk EG0013 events3 affected1,253 at risk
Multi-system failure - Heart failure	Cardiac disorders	BSC coding list	Systematic Assessment	EG00081 events76 affected1,247 at risk EG00163 events57 affected1,253 at risk
Hypotension	Vascular disorders	BSC coding list	Systematic Assessment	EG0009 events9 affected1,247 at risk EG00111 events10 affected1,253 at risk
Hypertension	Vascular disorders	BSC coding list	Systematic Assessment	EG0003 events3 affected1,247 at risk EG0013 events3 affected1,253 at risk
Cardiogenic shock	Cardiac disorders	BSC coding list	Systematic Assessment	EG0005 events5 affected1,247 at risk EG0019 events9 affected1,253 at risk
Cardiac arrest	Cardiac disorders	BSC coding list	Systematic Assessment	EG0007 events7 affected1,247 at risk EG00111 events11 affected1,253 at risk
Myocardial infarction	Cardiac disorders	BSC coding list	Systematic Assessment	EG00034 events34 affected1,247 at risk EG00129 events27 affected1,253 at risk
Coronary Artery Disease	Vascular disorders	BSC coding list	Systematic Assessment	EG000103 events83 affected1,247 at risk EG00163 events46 affected1,253 at risk
Vascular disease - unspecific	Vascular disorders	BSC coding list	Systematic Assessment	EG0005 events5 affected1,247 at risk EG0018 events6 affected1,253 at risk
Peripheral vascular disease	Vascular disorders	BSC coding list	Systematic Assessment	EG00055 events36 affected1,247 at risk EG00162 events37 affected1,253 at risk
Valve related - unspecific	Cardiac disorders	BSC coding list	Systematic Assessment	EG00013 events13 affected1,247 at risk EG00115 events13 affected1,253 at risk
Aortic stenosis	Vascular disorders	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0014 events4 affected1,253 at risk
Mitral stenosis	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0012 events1 affected1,253 at risk
Mitral regurgitation	Cardiac disorders	BSC coding list	Systematic Assessment	EG0003 events3 affected1,247 at risk EG0012 events2 affected1,253 at risk
Syncope	General disorders	BSC coding list	Systematic Assessment	EG00028 events26 affected1,247 at risk EG00141 events37 affected1,253 at risk
Dizziness	General disorders	BSC coding list	Systematic Assessment	EG0008 events8 affected1,247 at risk EG0012 events2 affected1,253 at risk
Chest pain - Ischemic	Cardiac disorders	BSC coding list	Systematic Assessment	EG00025 events20 affected1,247 at risk EG00124 events21 affected1,253 at risk
Chest pain - Other	General disorders	BSC coding list	Systematic Assessment	EG00023 events22 affected1,247 at risk EG00122 events19 affected1,253 at risk
Dyspnea	General disorders	BSC coding list	Systematic Assessment	EG0009 events9 affected1,247 at risk EG0019 events9 affected1,253 at risk
Palpitations	General disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0013 events3 affected1,253 at risk
Fatigue	General disorders	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0010 events0 affected1,253 at risk
Other- Patient condition - Cardiovascular	General disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0011 events1 affected1,253 at risk
Thromboembolic events - unspecific	Vascular disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
Transient ischemic attack (TIA)	Vascular disorders	BSC coding list	Systematic Assessment	EG0009 events9 affected1,247 at risk EG00112 events12 affected1,253 at risk
Cerebrovascular accident (CVA)	Vascular disorders	BSC coding list	Systematic Assessment	EG00034 events33 affected1,247 at risk EG00126 events23 affected1,253 at risk
Deep vein thrombosis (DVT)	Vascular disorders	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0011 events1 affected1,253 at risk
Pulmonary embolism (PE)	Vascular disorders	BSC coding list	Systematic Assessment	EG0006 events6 affected1,247 at risk EG0016 events6 affected1,253 at risk
Distal thromboemboli	Vascular disorders	BSC coding list	Systematic Assessment	EG0008 events8 affected1,247 at risk EG00110 events8 affected1,253 at risk
Intracardiac thrombus	Vascular disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0010 events0 affected1,253 at risk
Procedure related complication other than implant procedure	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG00021 events16 affected1,247 at risk EG00112 events12 affected1,253 at risk
Pericardial effusion - Unrelated to procedure	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0015 events5 affected1,253 at risk
Pericarditis	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
Hematoma	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0009 events9 affected1,247 at risk EG0015 events5 affected1,253 at risk
Hemorrhage	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0007 events6 affected1,247 at risk EG0016 events5 affected1,253 at risk
Adverse reaction - Allergic reaction	Immune system disorders	BSC coding list	Systematic Assessment	EG0003 events3 affected1,247 at risk EG0012 events2 affected1,253 at risk
Vasovagal reaction	Vascular disorders	BSC coding list	Systematic Assessment	EG0003 events3 affected1,247 at risk EG0012 events2 affected1,253 at risk
COPD exacerbation	Respiratory, thoracic and mediastinal disorders	BSC coding list	Systematic Assessment	EG00037 events24 affected1,247 at risk EG00125 events15 affected1,253 at risk
WHOLE BODY	General disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0010 events0 affected1,253 at risk
Death - Reason unspecified	General disorders	BSC coding list	Systematic Assessment	EG00046 events46 affected1,247 at risk EG00150 events50 affected1,253 at risk
Systemic infection	Infections and infestations	BSC coding list	Systematic Assessment	EG00052 events46 affected1,247 at risk EG00140 events36 affected1,253 at risk
Fever	General disorders	BSC coding list	Systematic Assessment	EG00010 events9 affected1,247 at risk EG0013 events3 affected1,253 at risk
Physical trauma	General disorders	BSC coding list	Systematic Assessment	EG00032 events29 affected1,247 at risk EG00142 events37 affected1,253 at risk
Abnormal laboratory values	Blood and lymphatic system disorders	BSC coding list	Systematic Assessment	EG0008 events8 affected1,247 at risk EG0018 events8 affected1,253 at risk
Hematological	Blood and lymphatic system disorders	BSC coding list	Systematic Assessment	EG00024 events19 affected1,247 at risk EG00117 events15 affected1,253 at risk
Neurological	Nervous system disorders	BSC coding list	Systematic Assessment	EG00017 events15 affected1,247 at risk EG00120 events18 affected1,253 at risk
Gastrointestinal	Gastrointestinal disorders	BSC coding list	Systematic Assessment	EG000132 events95 affected1,247 at risk EG001147 events115 affected1,253 at risk
Pulmonary	Respiratory, thoracic and mediastinal disorders	BSC coding list	Systematic Assessment	EG000123 events94 affected1,247 at risk EG001115 events95 affected1,253 at risk
Genitourinary	Renal and urinary disorders	BSC coding list	Systematic Assessment	EG00033 events26 affected1,247 at risk EG00146 events38 affected1,253 at risk
Renal	Renal and urinary disorders	BSC coding list	Systematic Assessment	EG00061 events54 affected1,247 at risk EG00152 events41 affected1,253 at risk
Musculoskeletal	Musculoskeletal and connective tissue disorders	BSC coding list	Systematic Assessment	EG00046 events41 affected1,247 at risk EG00138 events34 affected1,253 at risk
Psychological	Psychiatric disorders	BSC coding list	Systematic Assessment	EG00012 events11 affected1,247 at risk EG00117 events14 affected1,253 at risk
Integumentary	Skin and subcutaneous tissue disorders	BSC coding list	Systematic Assessment	EG00023 events20 affected1,247 at risk EG00110 events10 affected1,253 at risk
Head, eyes, ears, nose, throat (HEENT)	General disorders	BSC coding list	Systematic Assessment	EG00039 events31 affected1,247 at risk EG00125 events23 affected1,253 at risk
Endocrine	Endocrine disorders	BSC coding list	Systematic Assessment	EG00028 events25 affected1,247 at risk EG00135 events32 affected1,253 at risk
Immune	Immune system disorders	BSC coding list	Systematic Assessment	EG0003 events3 affected1,247 at risk EG0013 events3 affected1,253 at risk
Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	BSC coding list	Systematic Assessment	EG00081 events61 affected1,247 at risk EG00191 events60 affected1,253 at risk
Multi-system failure	General disorders	BSC coding list	Systematic Assessment	EG0007 events7 affected1,247 at risk EG00112 events12 affected1,253 at risk
	General disorders	BSC coding list	Systematic Assessment	EG00014 events13 affected1,247 at risk EG00115 events14 affected1,253 at risk
Adverse drug reaction	General disorders	BSC coding list	Systematic Assessment	EG00014 events14 affected1,247 at risk EG00113 events13 affected1,253 at risk
	General disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
PG System	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0010 events0 affected1,253 at risk
Oversensing - RA	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0010 events0 affected1,253 at risk
Other - PG system	Cardiac disorders	BSC coding list	Systematic Assessment	EG0003 events3 affected1,247 at risk EG0010 events0 affected1,253 at risk
Unable to convert - Defibrillation	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0012 events2 affected1,253 at risk
Elevated DFT - Defibrillation	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0013 events3 affected1,253 at risk
PG system - Therapy	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0011 events1 affected1,253 at risk
Inappropriate AV Delay	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0010 events0 affected1,253 at risk
Inappropriate tachy therapy - SVT	Cardiac disorders	BSC coding list	Systematic Assessment	EG00023 events20 affected1,247 at risk EG00133 events22 affected1,253 at risk
Inappropriate tachy therapy - NSR	Cardiac disorders	BSC coding list	Systematic Assessment	EG0004 events4 affected1,247 at risk EG0016 events6 affected1,253 at risk
Inappropriate tachy therapy - Noise	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0012 events2 affected1,253 at risk
Inappropriate tachy therapy - Other	Cardiac disorders	BSC coding list	Systematic Assessment	EG0004 events4 affected1,247 at risk EG0011 events1 affected1,253 at risk
Early ERI - Premature declaration	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0010 events0 affected1,253 at risk
Pacemaker-mediated tachycardia	Cardiac disorders	BSC coding list	Systematic Assessment	EG0006 events6 affected1,247 at risk EG0014 events3 affected1,253 at risk
PG system - Diagnosis	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0010 events0 affected1,253 at risk
Inability to maintain telemetry	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0015 events5 affected1,253 at risk
PG System - Patient related	Cardiac disorders	BSC coding list	Systematic Assessment	EG0006 events6 affected1,247 at risk EG0013 events3 affected1,253 at risk
PG system - Infection (> 30 days post implant)	Infections and infestations	BSC coding list	Systematic Assessment	EG0005 events5 affected1,247 at risk EG0013 events3 affected1,253 at risk
Psychological effect due to device therapy	Psychiatric disorders	BSC coding list	Systematic Assessment	EG0004 events3 affected1,247 at risk EG0013 events3 affected1,253 at risk
Hematoma - Pocket (> 30 days post implant)	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0010 events0 affected1,253 at risk
Migration	Skin and subcutaneous tissue disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
Post-surgical wound discomfort	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG00020 events20 affected1,247 at risk EG00124 events21 affected1,253 at risk
Post-surgical pocket hemorrhage	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0012 events2 affected1,253 at risk
Post-surgical infection (<= 30 days post-implant)	Infections and infestations	BSC coding list	Systematic Assessment	EG0008 events8 affected1,247 at risk EG0015 events4 affected1,253 at risk
Adverse reaction - General	General disorders	BSC coding list	Systematic Assessment	EG0006 events6 affected1,247 at risk EG0012 events2 affected1,253 at risk
Adverse reaction - Respiratory	Respiratory, thoracic and mediastinal disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0013 events3 affected1,253 at risk
Adverse reaction - Bradycardia	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0011 events1 affected1,253 at risk
Adverse reaction - Hypotension	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0003 events3 affected1,247 at risk EG0014 events4 affected1,253 at risk
Vasovagal	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0005 events5 affected1,247 at risk EG0012 events2 affected1,253 at risk
Hemodynamic instability - DFT testing	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0012 events2 affected1,253 at risk
Inadvertent VT/VF	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0012 events2 affected1,253 at risk
Inadvertent SVT	Cardiac disorders	BSC coding list	Systematic Assessment	EG0005 events5 affected1,247 at risk EG0014 events4 affected1,253 at risk
Chest pain	General disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0011 events1 affected1,253 at risk
Hemorrhage	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0011 events1 affected1,253 at risk
Physical trauma	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0006 events6 affected1,247 at risk EG0019 events7 affected1,253 at risk
Hematoma - Pocket (<=30 days post-implant)	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG00061 events60 affected1,247 at risk EG00151 events51 affected1,253 at risk
Seroma - Pocket (<=30 days post-implant)	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0004 events4 affected1,247 at risk EG0012 events2 affected1,253 at risk
Thromboembolic events	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0003 events3 affected1,247 at risk EG00110 events10 affected1,253 at risk
Other - PG system - Procedure	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0011 events1 affected1,253 at risk
Oversensing - RA	Cardiac disorders	BSC coding list	Systematic Assessment	EG0003 events3 affected1,247 at risk EG0012 events2 affected1,253 at risk
Undersensing - RA	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0012 events2 affected1,253 at risk
Unable to capture - RA	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0013 events3 affected1,253 at risk
Elevated threshold - RA	Cardiac disorders	BSC coding list	Systematic Assessment	EG0006 events6 affected1,247 at risk EG00110 events10 affected1,253 at risk
Extracardiac stimulation - RA	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
Electrode damaged - RA	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0010 events0 affected1,253 at risk
Impedance > 2000 ohms - RA	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0011 events1 affected1,253 at risk
Dislodgment - Unable to capture - RA	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
Dislodgment - Elevated threshold - RA	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0010 events0 affected1,253 at risk
Dislodgment - Extracardiac stimulation- RA	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
Dislodgment - Multiple signs - RA	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0011 events1 affected1,253 at risk
Dislodgment - No reported signs - RA	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0013 events3 affected1,253 at risk
Other - Lead	Cardiac disorders	BSC coding list	Systematic Assessment	EG0004 events4 affected1,247 at risk EG0019 events8 affected1,253 at risk
Oversensing - RV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0003 events3 affected1,247 at risk EG0011 events1 affected1,253 at risk
Unable to capture - RV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
Elevated threshold - RV	Cardiac disorders	BSC coding list	Systematic Assessment	EG00016 events16 affected1,247 at risk EG00115 events15 affected1,253 at risk
Conductor coil fracture - RV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
Impedance < 300 ohms - RV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0010 events0 affected1,253 at risk
Dislodgment - Elevated threshold -RV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0012 events2 affected1,253 at risk
Dislodgment - Multiple signs - RV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
Dislodgment - No reported signs - RV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0010 events0 affected1,253 at risk
Unable to capture - LV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0004 events4 affected1,247 at risk EG0011 events1 affected1,253 at risk
Elevated threshold - LV	Cardiac disorders	BSC coding list	Systematic Assessment	EG00020 events19 affected1,247 at risk EG00121 events21 affected1,253 at risk
Extracardiac stimulation - LV	Cardiac disorders	BSC coding list	Systematic Assessment	EG00041 events32 affected1,247 at risk EG00145 events36 affected1,253 at risk
Electrode damaged - LV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
Dislodgment - Unable to capture - LV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
Dislodgment - Elevated threshold - LV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
Dislodgment - Multiple signs - LV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0011 events1 affected1,253 at risk
Dislodgment - No reported signs -LV	Cardiac disorders	BSC coding list	Systematic Assessment	EG0003 events3 affected1,247 at risk EG0011 events1 affected1,253 at risk
Defibrillation lead	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0011 events1 affected1,253 at risk
Oversensing - Defibrillation lead	Cardiac disorders	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0012 events2 affected1,253 at risk
Undersensing - Defibrillation lead	Cardiac disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
Elevated DFT - Defibrillation lead	Cardiac disorders	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0012 events2 affected1,253 at risk
Arterial perforation - Procedure	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0010 events0 affected1,253 at risk
Pneumothorax - Procedure	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0014 events4 affected1,253 at risk
Renal failure due to contrast media - Procedure	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0011 events1 affected1,253 at risk
Pleural effusion - Procedure	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0004 events4 affected1,247 at risk EG0014 events4 affected1,253 at risk
Coronary venous dissection	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0008 events8 affected1,247 at risk EG0013 events3 affected1,253 at risk
AV block (transient) - Procedure	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0003 events3 affected1,247 at risk EG0010 events0 affected1,253 at risk
Pericardial effusion	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0012 events2 affected1,253 at risk
Other - Lead - Procedure	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG00024 events23 affected1,247 at risk EG00127 events27 affected1,253 at risk
Patient CONDITION Cardiovascular	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0011 events1 affected1,253 at risk
Bradyarrhythmias - unspecific	Cardiac disorders	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0010 events0 affected1,253 at risk
1st degree AV block	Cardiac disorders	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0010 events0 affected1,253 at risk
2nd degree AV block	Cardiac disorders	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0010 events0 affected1,253 at risk
3rd degree AV block	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0010 events0 affected1,253 at risk
Sinus bradycardia	Cardiac disorders	BSC coding list	Systematic Assessment	EG0003 events3 affected1,247 at risk EG0014 events4 affected1,253 at risk
Chronotropic incompetence	Cardiac disorders	BSC coding list	Systematic Assessment	EG0003 events3 affected1,247 at risk EG0012 events2 affected1,253 at risk
Ventricular tachyarrhythmias - unspecified	Cardiac disorders	BSC coding list	Systematic Assessment	EG0003 events3 affected1,247 at risk EG0012 events2 affected1,253 at risk
Ventricular fibrillation (VF)	Cardiac disorders	BSC coding list	Systematic Assessment	EG0007 events2 affected1,247 at risk EG0015 events5 affected1,253 at risk
Ventricular tachycardia (VT)	Cardiac disorders	BSC coding list	Systematic Assessment	EG00025 events23 affected1,247 at risk EG00139 events33 affected1,253 at risk
Nonsustained ventricular tachycardia (NSVT)	Cardiac disorders	BSC coding list	Systematic Assessment	EG00010 events7 affected1,247 at risk EG00117 events14 affected1,253 at risk
Accelerated idiopathic rhythm	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0010 events0 affected1,253 at risk
Atrial Tachyarrhythmias - unspecific	Cardiac disorders	BSC coding list	Systematic Assessment	EG0006 events6 affected1,247 at risk EG0011 events1 affected1,253 at risk
Atrial fibrillation (AF)	Cardiac disorders	BSC coding list	Systematic Assessment	EG00049 events45 affected1,247 at risk EG00149 events43 affected1,253 at risk
Atrial flutter	Cardiac disorders	BSC coding list	Systematic Assessment	EG00013 events12 affected1,247 at risk EG0016 events6 affected1,253 at risk
Sinus Tachycardia	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0013 events3 affected1,253 at risk
Other SVT (eg AVRT, AVNRT, EAT)	Cardiac disorders	BSC coding list	Systematic Assessment	EG0004 events4 affected1,247 at risk EG0016 events5 affected1,253 at risk
Premature ventricular contractions (PVC)	Cardiac disorders	BSC coding list	Systematic Assessment	EG0007 events7 affected1,247 at risk EG0016 events5 affected1,253 at risk
Syncope - Heart failure	Cardiac disorders	BSC coding list	Systematic Assessment	EG0003 events3 affected1,247 at risk EG0010 events0 affected1,253 at risk
Dizziness - Heart failure	Cardiac disorders	BSC coding list	Systematic Assessment	EG0005 events4 affected1,247 at risk EG0014 events2 affected1,253 at risk
Chest pain - Heart failure	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0014 events4 affected1,253 at risk
Dyspnea - Heart failure	Cardiac disorders	BSC coding list	Systematic Assessment	EG00037 events34 affected1,247 at risk EG00129 events29 affected1,253 at risk
Peripheral edema - Heart failure	Cardiac disorders	BSC coding list	Systematic Assessment	EG00015 events15 affected1,247 at risk EG00111 events11 affected1,253 at risk
Pulmonary edema - Heart failure	Respiratory, thoracic and mediastinal disorders	BSC coding list	Systematic Assessment	EG0006 events5 affected1,247 at risk EG0012 events2 affected1,253 at risk
Fatigue - Heart failure	Cardiac disorders	BSC coding list	Systematic Assessment	EG0006 events6 affected1,247 at risk EG0018 events6 affected1,253 at risk
Renal insufficiency - Heart failure	Renal and urinary disorders	BSC coding list	Systematic Assessment	EG0003 events3 affected1,247 at risk EG0012 events2 affected1,253 at risk
Dehydration - Heart failure	Cardiac disorders	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0011 events1 affected1,253 at risk
Weight gain - Heart failure	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0011 events1 affected1,253 at risk
Heart failure symptoms - Unspecified	Cardiac disorders	BSC coding list	Systematic Assessment	EG00010 events10 affected1,247 at risk EG0015 events5 affected1,253 at risk
Multiple heart failure symptoms	Cardiac disorders	BSC coding list	Systematic Assessment	EG00034 events31 affected1,247 at risk EG00139 events33 affected1,253 at risk
Hypertension - Heart failure	Cardiac disorders	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0010 events0 affected1,253 at risk
Other- Heart failure patient condition - Cardiovascular	Cardiac disorders	BSC coding list	Systematic Assessment	EG0005 events5 affected1,247 at risk EG0012 events2 affected1,253 at risk
Hypotension	Vascular disorders	BSC coding list	Systematic Assessment	EG00022 events22 affected1,247 at risk EG00119 events19 affected1,253 at risk
Hypertension	Vascular disorders	BSC coding list	Systematic Assessment	EG0009 events9 affected1,247 at risk EG00118 events15 affected1,253 at risk
Myocardial infarction	Cardiac disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0011 events1 affected1,253 at risk
Coronary Artery Disease	Vascular disorders	BSC coding list	Systematic Assessment	EG00019 events18 affected1,247 at risk EG00114 events14 affected1,253 at risk
Vascular disease - unspecific	Vascular disorders	BSC coding list	Systematic Assessment	EG0006 events6 affected1,247 at risk EG0014 events4 affected1,253 at risk
Peripheral vascular disease	Vascular disorders	BSC coding list	Systematic Assessment	EG00012 events12 affected1,247 at risk EG0017 events5 affected1,253 at risk
Valve related - unspecific	Cardiac disorders	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0011 events1 affected1,253 at risk
Syncope	General disorders	BSC coding list	Systematic Assessment	EG00048 events43 affected1,247 at risk EG00131 events27 affected1,253 at risk
Dizziness	General disorders	BSC coding list	Systematic Assessment	EG00030 events26 affected1,247 at risk EG00138 events36 affected1,253 at risk
Chest pain - Ischemic	Cardiac disorders	BSC coding list	Systematic Assessment	EG00011 events10 affected1,247 at risk EG00111 events11 affected1,253 at risk
Chest pain - Other	General disorders	BSC coding list	Systematic Assessment	EG00028 events17 affected1,247 at risk EG00123 events19 affected1,253 at risk
Dyspnea	General disorders	BSC coding list	Systematic Assessment	EG00020 events19 affected1,247 at risk EG00112 events12 affected1,253 at risk
Palpitations	General disorders	BSC coding list	Systematic Assessment	EG00013 events12 affected1,247 at risk EG0019 events9 affected1,253 at risk
Fatigue	General disorders	BSC coding list	Systematic Assessment	EG00010 events10 affected1,247 at risk EG0016 events6 affected1,253 at risk
Multiple Symptoms	General disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0014 events4 affected1,253 at risk
Thromboembolic events - unspecific	Vascular disorders	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0011 events1 affected1,253 at risk
Transient ischemic attack (TIA)	Vascular disorders	BSC coding list	Systematic Assessment	EG0005 events5 affected1,247 at risk EG0013 events3 affected1,253 at risk
Cerebrovascular accident (CVA)	Vascular disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0012 events2 affected1,253 at risk
Deep vein thrombosis (DVT)	Vascular disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0011 events1 affected1,253 at risk
Distal thromboemboli	Vascular disorders	BSC coding list	Systematic Assessment	EG0004 events4 affected1,247 at risk EG0011 events1 affected1,253 at risk
Intracardiac thrombus	Cardiac disorders	BSC coding list	Systematic Assessment	EG0003 events3 affected1,247 at risk EG0012 events2 affected1,253 at risk
Procedure related complication other than implant procedure	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG00010 events7 affected1,247 at risk EG0014 events4 affected1,253 at risk
Pericardial effusion - Unrelated to procedure	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0010 events0 affected1,253 at risk
Pericarditis	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0002 events1 affected1,247 at risk EG0010 events0 affected1,253 at risk
Hematoma	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0005 events5 affected1,247 at risk EG0013 events3 affected1,253 at risk
Hemorrhage	Surgical and medical procedures	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0010 events0 affected1,253 at risk
Adverse reaction - Allergic reaction	Immune system disorders	BSC coding list	Systematic Assessment	EG0006 events6 affected1,247 at risk EG0017 events7 affected1,253 at risk
Vasovagal reaction	Vascular disorders	BSC coding list	Systematic Assessment	EG0005 events5 affected1,247 at risk EG0015 events5 affected1,253 at risk
COPD exacerbation	Respiratory, thoracic and mediastinal disorders	BSC coding list	Systematic Assessment	EG0007 events7 affected1,247 at risk EG0015 events5 affected1,253 at risk
WHOLE BODY	General disorders	BSC coding list	Systematic Assessment	EG0000 events0 affected1,247 at risk EG0012 events2 affected1,253 at risk
Systemic infection	Infections and infestations	BSC coding list	Systematic Assessment	EG00018 events17 affected1,247 at risk EG0013 events3 affected1,253 at risk
Fever	General disorders	BSC coding list	Systematic Assessment	EG0008 events8 affected1,247 at risk EG0011 events1 affected1,253 at risk
Physical trauma	General disorders	BSC coding list	Systematic Assessment	EG00046 events41 affected1,247 at risk EG00131 events30 affected1,253 at risk
Abnormal laboratory values	Blood and lymphatic system disorders	BSC coding list	Systematic Assessment	EG00015 events14 affected1,247 at risk EG0015 events5 affected1,253 at risk
Hematological	Blood and lymphatic system disorders	BSC coding list	Systematic Assessment	EG00020 events18 affected1,247 at risk EG00114 events12 affected1,253 at risk
Neurological	Nervous system disorders	BSC coding list	Systematic Assessment	EG00017 events16 affected1,247 at risk EG00124 events16 affected1,253 at risk
Gastrointestinal	Gastrointestinal disorders	BSC coding list	Systematic Assessment	EG00062 events49 affected1,247 at risk EG00164 events56 affected1,253 at risk
Pulmonary	Respiratory, thoracic and mediastinal disorders	BSC coding list	Systematic Assessment	EG00054 events48 affected1,247 at risk EG00168 events59 affected1,253 at risk
Genitourinary	Renal and urinary disorders	BSC coding list	Systematic Assessment	EG00049 events38 affected1,247 at risk EG00132 events28 affected1,253 at risk
Renal	Renal and urinary disorders	BSC coding list	Systematic Assessment	EG00022 events20 affected1,247 at risk EG00114 events14 affected1,253 at risk
Musculoskeletal	Musculoskeletal and connective tissue disorders	BSC coding list	Systematic Assessment	EG00061 events51 affected1,247 at risk EG00152 events49 affected1,253 at risk
Psychological	Psychiatric disorders	BSC coding list	Systematic Assessment	EG0008 events8 affected1,247 at risk EG00114 events14 affected1,253 at risk
Integumentary	Skin and subcutaneous tissue disorders	BSC coding list	Systematic Assessment	EG00032 events30 affected1,247 at risk EG00132 events30 affected1,253 at risk
Head, eyes, ears, nose, throat (HEENT)	General disorders	BSC coding list	Systematic Assessment	EG00061 events53 affected1,247 at risk EG00153 events49 affected1,253 at risk
Endocrine	Endocrine disorders	BSC coding list	Systematic Assessment	EG00049 events41 affected1,247 at risk EG00144 events38 affected1,253 at risk
Immune	Immune system disorders	BSC coding list	Systematic Assessment	EG0002 events2 affected1,247 at risk EG0011 events1 affected1,253 at risk
Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	BSC coding list	Systematic Assessment	EG00017 events14 affected1,247 at risk EG00115 events13 affected1,253 at risk
	General disorders	BSC coding list	Systematic Assessment	EG00017 events16 affected1,247 at risk EG00123 events21 affected1,253 at risk
Adverse drug reaction	General disorders	BSC coding list	Systematic Assessment	EG00030 events26 affected1,247 at risk EG00127 events25 affected1,253 at risk
	General disorders	BSC coding list	Systematic Assessment	EG0001 events1 affected1,247 at risk EG0010 events0 affected1,253 at risk

ID	Term
D014693	Ventricular Fibrillation
D017180	Tachycardia, Ventricular

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D013610	Tachycardia
D000075224	Cardiac Conduction System Disease

ID	Term
D047548	Defibrillators
D004566	Electrodes
D055615	Electrical Equipment and Supplies
D004864	Equipment and Supplies
D004567	Electrodes, Implanted
D019736	Prostheses and Implants

ID	Title	Description
BG000	ICD Implant Without Defibrillation Testing	Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
BG001	ICD Implant With Defibrillation Testing	Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant.
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	ICD Implant Without Defibrillation Testing	Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.			776	1,247	625	1,247
EG001	ICD Implant With Defibrillation Testing	Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant.			790	1,253	632	1,253