Spreadsheet: 194a3897-445c-4133-9ad3-c20d7804e778
Sheet: Sheet1

CRM Device Dataset | Unnamed: 1 | Unnamed: 2 | Version: | 5.01 | Field count:  116
Pacemaker/ICD/Implantable Monitor Database |  |  | Date: | 2013-09-25 00:00:00
 | Field Description | Long Code | Field Type | Notes | List for Software Developers
Index | SECTION 1: DEMOGRAPHICS
1 | Dataset version | Static value "5.01" | Text (single value) | Static value "5.01" | 5.01
1.01 | Hospital identifier | ACH. [NAME] ... ZZZ. St Elsewhere's | Text (single value) | The identifier allocated to the hospital by CCAD. Used for the identification and analysis of the individual centre data. Valid Hospital Identifiers are listed in a separate file. The software should set this field without any user involvement. | ACH. [NAME] ... ZZZ. St Elsewhere's
1.02 | Patient Case Record Number | Free text | Text (single value) | The permanent number for identifying the patient across all departments within the hospital. The CCAD Hospital identifier and this field are used to link records from the same hospital for the same patient. Separate episodes for the same patient may not be linked correctly unless the permanent identifier for the patient is used.
1.03 | NHS Number | 10 digit (no spaces) valid NHS Number | Text (single value) | Unique national identifier for patient. CCAD uses the NHS number to obtain the patient's life status and to link records for the same patient from different hospitals.
1.04 | Patient Surname | Free text | Text (single value)
1.05 | Patient Forename | Free text | Text (single value)
1.06 | Patient Date of Birth | Valid date >1880 and <=Today | Date (dd/mm/yyyy)
1.07 | Patient Sex | 0. Not known 1. Male 2. Female | Text (single value) |  | 0. Not known 1. Male 2. Female
1.08 | Patient Post Code | Valid Post Code | Text (single value) | The NHS standard requires the use of the full post code
1.09 | Status | 1. NHS 2. Private 5. Overseas | Text (single value) | NHS Private (UK Citizen) Overseas Citizen (NHS or private) | 1. NHS 2. Private 5. Overseas
 | SECTION 2: BASELINE DATA |  |  | Notes
2.01 | Date of first implant |  | Date (dd/mm/yyyy) | If you do not know the date of first implant, leave this field blank.
2.02 | PreDevice Aetiology | • Apparently normal heart • Ischaemic heart disease • Congenital - conduction only • Congenital - structural • Cardiac surgery • Catheter ablation  • Percutaneous structural cardiac intervention • Reflex - carotid sinus syndrome • Reflex - vasovagal • Reflex  - other  • Cardiomyopathy - dilated • Cardiomyopathy - hypertrophic [NAME] RV dysplasia • Cardiomyopathy - amyloid • Cardiomyopathy - sarcoid [NAME] - other (specify in comments) • Endocarditis • Myocarditis • Valve disease - operated/intervened • Valve disease  - no intervention • Cardiac Transplant • Channelopathy - long QT syndrome [NAME] syndrome [NAME]  - other (specify in comments) [NAME] dystrophy • Other (specify in comments) • Unknown | Text (multivalue ; separated) | NB: for several years Aetiology ha snot been collected for pacemakers, only for complex devices, but from April 2014 users should again collect Aetiology for all device implants.  We have made the choices simpler! | B3. Apparently normal heart C1. Ischaemic heart disease D1A. Congenital - conduction only D1B. Congenital - structural E1. Cardiac surgery E3. Catheter ablation  E4. Percutaneous structural cardiac intervention F1. Reflex - carotid sinus syndrome F2. [NAME]F4. [NAME]  [NAME] - dilated [NAME] [NAME] RV dysplasia [NAME] [NAME] G1X. Cardiomyopathy - other (specify in comments) G6. Endocarditis G2. Myocarditis G3A. Valve disease - operated/intervened G3B. Valve disease  - no intervention G7. Cardiac Transplant H2. [NAME] QT syndrome H5. [NAME] syndrome H9. [NAME] other (specify in comments) K1. Myotonic dystrophy H3. Other (specify in comments) Z1. Unknown
2.03 | PreDevice Symptom | • None/Prophylactic • Syncope • Cardiac Arrest • Aborted Sudden Death • Dizzy Spells • Palpitations • Fatigue/dyspnoea/heart failure • Chest Pain • Other (specify in comments) • Unknown | Text (multivalue ; separated) |  | D1. None/Prophylactic B1. Syncope B4. Cardiac Arrest D5. Aborted [NAME] B2. [NAME] Palpitations D2. Fatigue/dyspnoea/heart failure D4. Chest Pain A3. Other Z1. Unknown
2.04 | ECG Indication for Device | • No bradycardia or arrhythmia documented (prophylactic implant) • Abnormal EPS only • Sinus node - bradycardia, pauses, SSS • Sinus node - chronotropic incompetence • 1⁰ AV block (long PR) • 2⁰ AV block Mobitz 1 (Wenckebach) • 2⁰ AV block Mobitz 2 • 2⁰ AV block sustained 2:1  • 3⁰ (complete) AV block • RBBB  • LBBB  • Bifascicular block  • Trifascicular block  • LBBB + long PR  • RBBB and LBBB alternating  • Bradycardia/pauses during sustained AT/AFL/AF • Sustained AT/AFL/AF with complete heart block  • Atrial tachycardia/flutter/fibrillation  • PVCs  • nonsustained VT/VF (inc. polymorphic VT not torsade) • sustained VT/VF (inc. polymorphic VT not torsade) • torsade de pointes  • Other (specify in comments) | Text (multivalue ; separated) | This replaces "pre-device ECG" to clarify that this is the INDICATION for the device, NOT the ECG on admission. | A3. No bradycardia or arrhythmia documented B2. Abnormal EPS only E1. Sinus node - bradycardia, pauses, SSS E8. Sinus node - chronotropic incompetence C1. 1⁰ AV block C3. 2⁰ AV block Mobitz 1 (Wenckebach) C4. 2⁰ AV block Mobitz 2 C4B. 2⁰ AV block sustained 2:1  C5. 3⁰ (complete) AV block D3. RBBB  D4. LBBB  D13. Bifascicular block  D14. Trifascicular block  D11. LBBB + long PR  D12. RBBB and LBBB alternating  E6. Bradycardia/pauses during sustained AT/AFL/AF C8. Sustained AT/AFL/AF with complete heart block  F1. Atrial tachycardia/flutter/fibrillation  G1. PVCs  G2. nonsustained VT/VF G3. sustained VT/VF G4. torsade de pointes  G5. Other
2.05 | Atrial rhythm at time of implant | • Sinus rhythm or paroxysmal atrial arrhythmia  • Sustained atrial arrhythmia  • Atrial standstill or purely paced atrial rhythm | Text (single value) |  | 1. Sinus rhythm or paroxysmal atrial arrhythmia  2. Sustained atrial arrhythmia  3. Atrial standstill or purely paced atrial rhythm
2.06 | Functional status (NYHA) | 1. No limitation of physical activity 2. Slight limitation of ordinary physical activity 3. Marked limitation of ordinary physical activity 4. Symptoms at rest or minimal activity 9. Unknown | Text (single value) | For ICD & CRT only | 1. No limitation of physical activity 2. Slight limitation of ordinary physical activity 3. Marked limitation of ordinary physical activity 4. Symptoms at rest or minimal activity 9. Unknown
2.07 | LV function | • Good (LVEF > 50%)  • Moderate (LVEF 35-50%)  • Poor (LVEF < 35%)  • Unknown | Text (single value) | For ICD & CRT only | 1. Good (LVEF > 50%) 2. Moderate (LVEF 35-50%) 3. Poor (LVEF < 35%) 9. Unknown
2.08 | ICD Indication | • Not applicable (not an ICD)  • Primary prevention  • Secondary prevention  • Other indication (specify in comments)  • Unknown | Text (single value) | For ICD only | 0. Not applicable 1. Primary prevention 2. Secondary prevention 8. Other indication 9. Unknown
2.09 | PreDevice/Ablation QRS duration | QRS duration (ms) | Numeric integer | For ICD & CRT only
2.1 | QRS morphology if >120ms | • N/A (≤120ms)  • LBBB  • RBBB  • Nonspecific intraventricular conduction delay  • Paced QRS | Text (single value) | For ICD & CRT only | 0. not applicable 1. LBBB 2. RBBB 3. Nonspecific intraventricular conduction delay 4. Paced QRS
 | SECTION 3: PROCEDURE DETAILS |  |  | Notes
3.01 | Procedure Date/time | Valid DateTime | DateTime (dd/mm/yyyy hh:[NAME]) | NB: please enter a time component if you wish to register multiple procedures on the same patient on the same day.
3.02 | First operator (scrubbed) NAME |  | Text
3.03 | First operator (scrubbed) GMC |  | Text
3.04 | First Operator (scrubbed) GRADE | • Consultant • Associate Specialist • SpR • Fellow/other trainee • Other medical grade (specify in comments) • Non-medical - nurse practitioner • Non-medical - physiologist • Other (specify in comments) | Text (single value) |  | 1. Consultant 2. Associate Specialist 3. SpR 4. Fellow/other trainee 5. Other medical grade (specify in comments) 6. Non-medical - nurse practitioner 7. Non-medical - physiologist 9. Other
3.05 | Second operator (scrubbed) NAME |  | Text
3.06 | Second operator (scrubbed) GMC |  | Text
3.07 | Second Operator (scrubbed) GRADE | • Consultant • Associate Specialist • SpR • Fellow/other trainee • Other medical grade (specify in comments) • Non-medical - nurse practitioner • Non-medical - physiologist • Other (specify in comments) | Text (single value) |  | 1. Consultant 2. Associate Specialist 3. SpR 4. Fellow/other trainee 5. Other medical grade (specify in comments) 6. Non-medical - nurse practitioner 7. Non-medical - physiologist 9. Other
3.08 | Consultant responsible NAME |  | Text
3.09 | Consultant responsible GMC |  | Text
3.1 | Consultant responsible GRADE | • Consultant • Associate Specialist | Text (single value) |  | 1. Consultant 2. Associate Specialist
3.11 | Intervention category | • New pacemaker/ICD system - FIRST IMPLANT  • Generator change only  • New generator and lead revision/change  • Upgrade - increased functionality (to DDD, [NAME], or ICD)  • Downgrade - decreased functionality  • System explant  • Wound revision/generator resite/haematoma  • Lead intervention only  • Monitor procedure only | Text (single value) | This field should identify type of procedure (especially first implant, simple box change versus others).   Subsequent fields will identify details. | 1. New pacemaker/ICD system - FIRST IMPLANT 2. Generator change only 3. New generator and lead revision/change 4. Upgrade - increased functionality (to DDD, [NAME], or ICD) 5. Downgrade - decreased functionality 6. System explant 7. Wound revision/generator resite/haematoma 8. Lead intervention only 9. Monitor procedure only
3.12 | Maximum system capability | AAI(R) VVI(R) DDD(R) CRT-P ICD-VR ICD-DR CRT-D ICD-SQ Monitor (passive device: ILR, PA monitor etc) None (e.g. lead only) | Text (single value) | This replaces "pacing mode at discharge".  NB this is the system (not generator) capability, so e.g. CRT-D generator with no LV lead is entered as ICD-DR | AAI(R) VVI(R) DDD(R) CRT-P ICD-VR ICD-DR CRT-D ICD-SQ Monitor None
3.13 | Fluoroscopy time | minutes
3.14 | Dose Area Product | mGy.cm2 |  | The absorbed dose multiplied by the area irradiated, expressed in milli-Gray square centimetres (mGy*cm²)
3.15 | Operation report/comment | (free for comments) | Free text | Text (single value)
 | [NAME]/DEVICE |  |  | Notes
3.16 | Generator/device procedure | • New generator    • Replacement generator  • Additional generator  • Generator repositioned/revised/reconnected  • Generator unchanged  • Generator removed  • Monitor implant  • Monitor revision/resite  • Monitor explant  • no generator present | Text (single value) | NEW FIELD.  "New generator" to be selected even if it is not the patient's first (e.g. following a period without device after lead extraction, or new device on other side from first).  NB: Proposed "Additional generator" implies the existing generator is still in place.   Procedures on two entirely separate devices (e.g. Pacemaker implant and ILR explant, replacement of system on other side) should be entered as two separate procedures, even if performed on the same occasion. | 1. New generator   2. Replacement generator 3. Additional generator 4. Generator repositioned/revised/reconnected 5. Generator unchanged 6. Generator removed 7. Monitor implant 8. Monitor revision/resite 9. Monitor explant 10. no generator present
3.17 | Generator/Device Implant site | • Chest wall - subcutaneous • Chest wall - submuscular [NAME] - subcutaneous [NAME] - submuscular • Intravascular - endocardial • Intravascular - pulmonary artery • Other (specify in comments) | Text (single value) |  | 1. Chest wall - subcutaneous 2. Chest wall - submuscular 3. Abdominal - subcutaneous 4. Abdominal - submuscular 5. Intravascular - endocardial 6. Intravascular - pulmonary artery 9. Other
3.18 | Reason for generator change/removal | • N/A (Generator new or unchanged) • Expected battery depletion • Accelerated battery depletion • Sudden/unexpected battery depletion • Generator fault/failure  • Generator recall • Changed medical indication - same leads (e.g. for new algorithm • system upgrade (more leads/add defibrillation) • system downgrade (fewer leads/no DF) • Protrusion/pre-erosion • Infection/erosion • In planned surgical/radiotherapy field | Text (single value) | If the generator is new this field can be left blank. | A1. Not applicable F1. Expected battery depletion F2. Accelerated battery depletion F4. Sudden/unexpected battery depletion E9. Generator fault/failure  C1. Protrusion/pre-erosion C3. Infection/erosion H1. Generator recall H2. Changed medical indication - same leads H3. system upgrade H4. system downgrade H5. In planned surgical/radiotherapy field
3.19 | Generator/Device Manufacturer | BSI. Boston Scientific BTK. Biotronik MED. Medtronic PAS. [NAME]. Sorin VIT. [NAME] | Text (single value) | Current (2012/3) manufacturers shown in this list. For updates contact the NICOR CRM Database Coordinator. | BSI. Boston Scientific BTK. Biotronik MED. Medtronic PAS. [NAME]. Sorin VIT. [NAME]
3.2 | Generator/Device Model |  | Text (single value) | No change
3.21 | Generator/Device Serial No |  | Text (single value) | No change
 | [NAME] |  |  | Notes
3.22 | Lead Intervention RV1 | • New RV lead • Existing RV lead unaltered • Additional RV lead • RV lead replacement • RV lead revision/reposition/reconnection • RV lead removal • No RV lead | Text (single value) | NEW FIELD.   NB: If there is an existing RV lead,  it can be repositioned, replaced, removed, or added to (entered as additional lead, even if existing lead is cut /capped).  If option 7 is selected no other fields need be completed. | 1. New RV lead 2. Existing RV lead unaltered 3. Additional RV lead 4. RV lead replacement 5. RV lead revision/reposition/reconnection 6. RV lead removal 7. No RV lead
3.23 | Access RV1 | • Cephalic  • Subclavian  • Axillary/subclavian extrathoracic  • External jugular  • Internal jugular  • Femoral  • Thoracotomy/sternotomy  • Other (specify in comments) | Text (single value) |  | 1.Cephalic 2. Subclavian 3. Axillary/subclavian extrathoracic 4. External jugular 5. Internal jugular 6. Femoral 7. Thoracotomy/sternotomy 9. Other
3.24 | Pacing site RV1 | • RV apex endocardial  • RV outflow endocardial  • RV septal  • RV epicardial (surgical)  • RV other (specify in comments) | Text (single value) |  | 1. RV apex endocardial 2. RV outflow endocardial 3. RV septal 4. RV epicardial (surgical) 9. RV other
3.25 | Main indication for RV1 lead revision/change/removal | • N/A (new lead) • Redundant (no longer indicated) • Macrodisplacement • Microdisplacement (high threshold/undersensing) • Perforation • Oversensing - T wave [NAME] - electromagnetic interference [NAME] - myopotential [NAME] - crosstalk • Suboptimal position - phrenic capture • Suboptimal position - DFT • Suboptimal position - dys-synchrony • Protrusion/discomfort/pre-erosion • Erosion/infection • Within planned surgical/radiotherapy • Lead problem - conductor fracture/high impedance  • Lead problem - insulation failure/low impedance • Lead problem - advisory/recall • Other (specify in comments) | Text (multivalue ; separated) |  | A1. not applicable - new lead B1. Redundant - no longer indicated B2A. Macrodisplacement B2B. Microdisplacement - high threshold/undersensing B6. Perforation B11. Oversensing - T wave B5. Oversensing - electromagnetic interference B4. Oversensing - myopotential B12. Oversensing - crosstalk E1. Suboptimal position - phrenic capture E2. Suboptimal position - DFT E3. Suboptimal position - dys-synchrony E4. Protrusion/discomfort/pre-erosion C4. Erosion/infection C3. Within planned surgical/radiotherapy D3. Lead problem - conductor fracture/high impedance  D2. Lead problem - insulation failure/low impedance B8. Lead problem - advisory/recall D4. Other
3.26 | [NAME] RV1 | BSI. Boston Scientific BTK. Biotronik MED. Medtronic OSC. Oscor PAS. [NAME]. Sorin VIT. [NAME] | Text (single value) | Current (2012/3) manufacturers shown in this list. For updates contact the NICOR CRM Database Coordinator. | BSI. Boston Scientific BTK. Biotronik MED. Medtronic OSC. Oscor PAS. [NAME]. Sorin VIT. [NAME]
3.27 | [NAME] | Valid model designation from relevant manufacturer | Text (single value)
3.28 | Lead Serial Number RV1 | Free text | Text (single value)
3.29 | Lead/Connector type RV1 | • IS1-bipolar • IS-1 unipolar • IS-1 + single DF-1 • Is-1 + 2xDF-1 • DF-4 • IS-4 • LV-1 • VS-1 bipolar • VS-1 unipolar • 5/6mm unippolar • other (specify) |  |  | 1. IS1-bipolar 2. IS-1 unipolar 3. IS-1 + single DF-1 4. Is-1 + 2xDF-1 5. DF-4 6. IS-4 7. LV-1 8. [NAME] bipolar 9. VS-1 unipolar 10. 5/6mm unippolar 99. other
 | [NAME]
3.3 | Lead Intervention RV2 | • New RV lead • Existing RV lead unaltered • Additional RV lead • RV lead replacement • RV lead revision/reposition/reconnection • RV lead removal • No RV lead | Text (single value) | NEW FIELD.   NB: If there is an existing RV lead,  it can be repositioned, replaced, removed, or added to (entered as additional lead, even if existing lead is cut /capped).  If option 7 is selected no other fields need be completed. | 1. New RV lead 2. Existing RV lead unaltered 3. Additional RV lead 4. RV lead replacement 5. RV lead revision/reposition/reconnection 6. RV lead removal 7. No RV lead
3.31 | Access RV2 | • Cephalic  • Subclavian  • Axillary/subclavian extrathoracic  • External jugular  • Internal jugular  • Femoral  • Thoracotomy/sternotomy  • Other (specify in comments) | Text (single value) |  | 1.Cephalic 2. Subclavian 3. Axillary/subclavian extrathoracic 4. External jugular 5. Internal jugular 6. Femoral 7. Thoracotomy/sternotomy 9. Other
3.32 | Pacing site RV2 | • RV apex endocardial  • RV outflow endocardial  • RV septal  • RV epicardial (surgical)  • RV other (specify in comments) | Text (single value) |  | 1. RV apex endocardial 2. RV outflow endocardial 3. RV septal 4. RV epicardial (surgical) 9. RV other
3.33 | Main indication for RV2 lead revision/change/removal | • N/A (new lead) • Redundant (no longer indicated) • Macrodisplacement • Microdisplacement (high threshold/undersensing) • Perforation • Oversensing - T wave [NAME] - electromagnetic interference [NAME] - myopotential [NAME] - crosstalk • Suboptimal position - phrenic capture • Suboptimal position - DFT • Suboptimal position - dys-synchrony • Protrusion/discomfort/pre-erosion • Erosion/infection • Within planned surgical/radiotherapy • Lead problem - conductor fracture/high impedance  • Lead problem - insulation failure/low impedance • Lead problem - advisory/recall • Other (specify in comments) | Text (multivalue ; separated) |  | A1. not applicable - new lead B1. Redundant - no longer indicated B2A. Macrodisplacement B2B. Microdisplacement - high threshold/undersensing B6. Perforation B11. Oversensing - T wave B5. Oversensing - electromagnetic interference B4. Oversensing - myopotential B12. Oversensing - crosstalk E1. Suboptimal position - phrenic capture E2. Suboptimal position - DFT E3. Suboptimal position - dys-synchrony E4. Protrusion/discomfort/pre-erosion C4. Erosion/infection C3. Within planned surgical/radiotherapy D3. Lead problem - conductor fracture/high impedance  D2. Lead problem - insulation failure/low impedance B8. Lead problem - advisory/recall D4. Other
3.34 | [NAME] RV2 | BSI. Boston Scientific BTK. Biotronik ELA. Sorin ELA MED. Medtronic OSC. Oscor PAS. [NAME]. Sorin STK. Stoeckert VIT. [NAME] | Text (single value) | Current (2012/3) manufacturers shown in this list. For updates contact the NICOR CRM Database Coordinator. | BSI. Boston Scientific BTK. Biotronik ELA. Sorin ELA MED. Medtronic OSC. Oscor PAS. [NAME]. Sorin STK. Stoeckert VIT. [NAME]
3.35 | [NAME] | Valid model designation from relevant manufacturer | Text (single value)
3.36 | Lead Serial Number RV2 | Free text | Text (single value)
3.37 | Lead/Connector type RV2 | • IS1-bipolar • IS-1 unipolar • IS-1 + single DF-1 • Is-1 + 2xDF-1 • DF-4 • IS-4 • LV-1 • VS-1 bipolar • VS-1 unipolar • 5/6mm unippolar • other (specify) |  |  | 1. IS1-bipolar 2. IS-1 unipolar 3. IS-1 + single DF-1 4. Is-1 + 2xDF-1 5. DF-4 6. IS-4 7. LV-1 8. [NAME] bipolar 9. VS-1 unipolar 10. 5/6mm unippolar 99. other
 | [NAME] Lead 1 |  |  | Notes
3.38 | Lead Intervention AL1 | • New RA lead • Existing RA lead unaltered  • Additional RA lead  • RA lead replacement  • RA lead revision/reposition/reconnection  • RA lead removal • No RA lead | Text (single value) | New field  If option 7 is selected no other fields need be completed. | 1. New RA lead 2. Existing RA lead unaltered 3. Additional RA lead 4. RA lead replacement 5. RA lead revision/reposition/reconnection 6. RA lead removal 7. No RA lead
3.39 | Access AL1 | • Cephalic  • Subclavian  • Axillary/subclavian extrathoracic  • External jugular  • Internal jugular  • Femoral  • Thoracotomy/sternotomy  • Other (specify in comments) | Text (single value) |  | 1.Cephalic 2. Subclavian 3. Axillary/subclavian extrathoracic 4. External jugular 5. Internal jugular 6. Femoral 7. Thoracotomy/sternotomy 9. Other
3.4 | Pacing site AL1 | • RA endocardial  • LA via CS  • Epicardial (surgical)  • Atrial other (specify in comments) | Text (single value) |  | 1. RA endocardial 2. LA via CS 4. [NAME] (surgical) 9. Atrial other
3.41 | Main indication for AL1 lead revision/change/removal | • N/A (new lead)  • Redundant (no longer indicated)  • Macrodisplacement  • Microdisplacement - high threshold/undersensing  • Perforation • Oversensing - T wave [NAME] - electromagnetic interference [NAME] - myopotential [NAME] crosstalk  • Suboptimal position - phrenic capture  • Suboptimal position - other (specify in comments)  • Protrusion/discomfort/pre-erosion  • Erosion/infection  • Within surgical/radiotherapy field  • Lead problem - conductor fracture/high impedance  • Lead problem - insulation failure/low impedance  • Lead problem  - advisory/recall  • Other (specify in comments) | Text (single value) |  | A1. not applicable - new lead B1. Redundant - no longer indicated B2A. Macrodisplacement B2B. Microdisplacement - high threshold/undersensing B6. Perforation B11. Oversensing - T wave B5. Oversensing - electromagnetic interference B4. Oversensing - myopotential B12. Oversensing - VA crosstalk E1. Suboptimal position - phrenic capture E9. Suboptimal position - other E4. Protrusion/discomfort/pre-erosion C4. Erosion/infection C3. Within planned surgical/radiotherapy D3. Lead problem - conductor fracture/high impedance  D2. Lead problem - insulation failure/low impedance B8. Lead problem - advisory/recall D4. Other
3.42 | [NAME] | BSI. Boston Scientific BTK. Biotronik ELA. Sorin ELA MED. Medtronic OSC. Oscor PAS. [NAME]. Sorin STK. Stoeckert VIT. [NAME] | Text (single value) | Current (2012/3) manufacturers shown in this list. For updates contact the NICOR CRM Database Coordinator. | BSI. Boston Scientific BTK. Biotronik ELA. Sorin ELA MED. Medtronic OSC. Oscor PAS. [NAME]. Sorin STK. Stoeckert VIT. [NAME]
3.43 | [NAME] | Valid model designation from relevant manufacturer | Text (single value)
3.44 | Lead Serial Number AL1 | Free text | Text (single value)
3.45 | Lead/Connector type AL1 | • IS1-bipolar • IS-1 unipolar • IS-1 + single DF-1 • Is-1 + 2x DF-1 • DF-4 • IS-4 • LV-1 • VS-1 bipolar • VS-1 unipolar • 5/6mm unippolar • other (specify) |  |  | 1. IS1-bipolar 2. IS-1 unipolar 4. Is-1 + 2xDF-1 8. [NAME] bipolar 9. VS-1 unipolar 10. 5/6mm unippolar 99. other
 | [NAME] Lead 2
3.46 | Lead Intervention AL2 | • New RA lead • Existing RA lead unaltered  • Additional RA lead  • RA lead replacement  • RA lead revision/reposition/reconnection  • RA lead removal • No RA lead | Text (single value) | New field  If option 7 is selected no other fields need be completed. | 1. New RA lead 2. Existing RA lead unaltered 3. Additional RA lead 4. RA lead replacement 5. RA lead revision/reposition/reconnection 6. RA lead removal 7. No RA lead
3.47 | [NAME] | • Cephalic  • Subclavian  • Axillary/subclavian extrathoracic  • External jugular  • Internal jugular  • Femoral  • Thoracotomy/sternotomy  • Other (specify in comments) | Text (single value) |  | 1.Cephalic 2. Subclavian 3. Axillary/subclavian extrathoracic 4. External jugular 5. Internal jugular 6. Femoral 7. Thoracotomy/sternotomy 9. Other
3.48 | Pacing site AL2 | • RA endocardial  • LA via CS  • Epicardial (surgical)  • Atrial other (specify in comments) | Text (single value) |  | 1. RA endocardial 2. LA via CS 4. [NAME] (surgical) 9. Atrial other
3.49 | Main indication for AL2 lead revision/change/removal | • N/A (new lead)  • Redundant (no longer indicated)  • Macrodisplacement  • Microdisplacement - high threshold/undersensing  • Perforation • Oversensing - T wave [NAME] - electromagnetic interference [NAME] - myopotential [NAME] crosstalk  • Suboptimal position - phrenic capture  • Suboptimal position - other (specify in comments)  • Protrusion/discomfort/pre-erosion  • Erosion/infection  • Within surgical/radiotherapy field  • Lead problem - conductor fracture/high impedance  • Lead problem - insulation failure/low impedance  • Lead problem  - advisory/recall  • Other (specify in comments) | Text (single value) |  | A1. not applicable - new lead B1. Redundant - no longer indicated B2A. Macrodisplacement B2B. Microdisplacement - high threshold/undersensing B6. Perforation B11. Oversensing - T wave B5. Oversensing - electromagnetic interference B4. Oversensing - myopotential B12. Oversensing - VA crosstalk E1. Suboptimal position - phrenic capture E9. Suboptimal position - other E4. Protrusion/discomfort/pre-erosion C4. Erosion/infection C3. Within planned surgical/radiotherapy D3. Lead problem - conductor fracture/high impedance  D2. Lead problem - insulation failure/low impedance B8. Lead problem - advisory/recall D4. Other
3.5 | [NAME] | BSI. Boston Scientific BTK. Biotronik ELA. Sorin ELA MED. Medtronic OSC. Oscor PAS. [NAME]. Sorin STK. Stoeckert VIT. [NAME] | Text (single value) | Current (2012/3) manufacturers shown in this list. For updates contact the NICOR CRM Database Coordinator. | BSI. Boston Scientific BTK. Biotronik ELA. Sorin ELA MED. Medtronic OSC. Oscor PAS. [NAME]. Sorin STK. Stoeckert VIT. [NAME]
3.51 | [NAME] | Valid model designation from relevant manufacturer | Text (single value)
3.52 | Lead Serial Number AL2 | Free text | Text (single value)
3.53 | Lead/Connector type AL2 | • IS1-bipolar • IS-1 unipolar • IS-1 + single DF-1 • IS-1 + 2x DF-1 • DF-4 • IS-4 • LV-1 • VS-1 bipolar • VS-1 unipolar • 5/6mm unippolar • other (specify) |  |  | 1. IS1-bipolar 2. IS-1 unipolar 4. Is-1 + 2xDF-1 8. [NAME] bipolar 9. VS-1 unipolar 10. 5/6mm unippolar 99. other
 | [NAME] |  |  | Notes
3.54 | Lead Intervention LV1 | • New LV lead • Existing LV lead unaltered • Additional LV lead • LV lead replacement • LV lead revision/reposition/reconnection • LV lead removal • No LV lead | Text (single value) | If option 7 is selected no other fields need be completed. | 1. New LV lead 2. Existing LV lead unaltered 3. Additional LV lead 4. LV lead replacement 5. LV lead revision/reposition/reconnection 6. LV lead removal 7. No LV lead
3.55 | [NAME] | • Cephalic  • Subclavian  • Axillary/subclavian extrathoracic  • External jugular  • Internal jugular  • Femoral  • Thoracotomy/sternotomy  • Pericardial puncture  • Other (specify in comments) | Text (single value) |  | 1.Cephalic 2. Subclavian 3. Axillary/subclavian extrathoracic 4. External jugular 5. Internal jugular 6. Femoral 7. Thoracotomy/sternotomy 8. Pericardial puncture 9. Other
3.56 | Pacing site [NAME] | • Middle cardiac vein • CS - Posterior branch [NAME] branch [NAME] branch • CS - Anterolateral branch • CS - Anterior branch • Greater cardiac vein  • LV epicardial (via pericardium)   • LV endocardial (trans-septal)  • LV other (specify in comments) | Text (single value) |  | 1. Middle cardiac vein 2. CS - Posterior branch 3. CS - Posterolateral branch 4. CS - Lateral branch 5. CS - Anterolateral branch 6. CS - Anterior branch 7. Greater cardiac vein 8. LV epicardial - via pericardium  9. LV endocardial - trans-septal 99. LV other
3.57 | Main indication for LV1 lead revision/change/removal | • N/A (new lead) • Redundant (no longer indicated) • Macrodisplacement • Microdisplacement/high threshold/undersensing • Perforation • Oversensing - T wave [NAME] - electromagnetic interference [NAME] - myopotential • Suboptimal position - phrenic capture • Suboptimal position - dys-synchrony  • Protrusion/discomfort/pre-erosion  • Erosion/infection  • Within surgical/radiotherapy field  • Lead problem - conductor fracture/high impedance  • Lead problem - insulation failure/low impedance  • Lead problem  - advisory/recall  • Other (specify in comments) | Text (multivalue ; separated) |  | A1. not applicable - new lead B1. Redundant - no longer indicated B2A. Macrodisplacement B2B. Microdisplacement - high threshold/undersensing B6. Perforation B11. Oversensing - T wave B5. Oversensing - electromagnetic interference B4. Oversensing - myopotential E1. Suboptimal position - phrenic capture E3. Suboptimal position - dys-synchrony E4. Protrusion/discomfort/pre-erosion C4. Erosion/infection C3. Within planned surgical/radiotherapy D3. Lead problem - conductor fracture/high impedance  D2. Lead problem - insulation failure/low impedance B8. Lead problem - advisory/recall D4. Other
3.58 | [NAME] | BSI. Boston Scientific BTK. Biotronik ELA. Sorin ELA MED. Medtronic OSC. Oscor PAS. [NAME]. Sorin STK. Stoeckert VIT. [NAME] | Text (single value) | Current (2012/3) manufacturers shown in this list. For updates contact the NICOR CRM Database Coordinator. | BSI. Boston Scientific BTK. Biotronik ELA. Sorin ELA MED. Medtronic OSC. Oscor PAS. [NAME]. Sorin STK. Stoeckert VIT. [NAME]
3.59 | [NAME] | Valid model designation from relevant manufacturer | Text (single value) | No change
3.6 | Lead Serial Number LV1 | Free text | Text (single value) | No change
3.61 | Lead/Connector type LV1 | • IS1-bipolar • IS-1 unipolar • IS-4 • LV-1 • Other (specify in comments) |  |  | 1. IS1-bipolar 2. IS-1 unipolar 6. IS-4 7. LV-1 99. other
 | [NAME]
3.62 | Lead Intervention LV2 | • New LV lead • Existing LV lead unaltered • Additional LV lead • LV lead replacement • LV lead revision/reposition/reconnection • LV lead removal • No LV lead | Text (single value) | If option 7 is selected no other fields need be completed. | 1. New LV lead 2. Existing LV lead unaltered 3. Additional LV lead 4. LV lead replacement 5. LV lead revision/reposition/reconnection 6. LV lead removal 7. No LV lead
3.63 | Access LV2 | • Cephalic  • Subclavian  • Axillary/subclavian extrathoracic  • External jugular  • Internal jugular  • Femoral  • Thoracotomy/sternotomy  • Pericardial puncture  • Other (specify in comments) | Text (single value) |  | 1.Cephalic 2. Subclavian 3. Axillary/subclavian extrathoracic 4. External jugular 5. Internal jugular 6. Femoral 7. Thoracotomy/sternotomy 8. Pericardial puncture 9. Other
3.64 | Pacing site LV2 | • Middle cardiac vein • CS - Posterior branch [NAME] branch [NAME] branch • CS - Anterolateral branch • CS - Anterior branch • Greater cardiac vein  • LV epicardial (via pericardium)   • LV endocardial (trans-septal)  • LV other (specify in comments) | Text (single value) |  | 1. Middle cardiac vein 2. CS - Posterior branch 3. CS - Posterolateral branch 4. CS - Lateral branch 5. CS - Anterolateral branch 6. CS - Anterior branch 7. Greater cardiac vein 8. LV epicardial - via pericardium  9. LV endocardial - trans-septal 99. LV other
3.65 | Main indication for LV2 lead revision/change/removal | • N/A (new lead) • Redundant (no longer indicated) • Macrodisplacement • Microdisplacement/high threshold/undersensing • Perforation • Oversensing - T wave [NAME] - electromagnetic interference [NAME] - myopotential • Suboptimal position - phrenic capture • Suboptimal position - dys-synchrony  • Protrusion/discomfort/pre-erosion  • Erosion/infection  • Within surgical/radiotherapy field  • Lead problem - conductor fracture/high impedance  • Lead problem - insulation failure/low impedance  • Lead problem  - advisory/recall  • Other (specify in comments) | Text (multivalue ; separated) |  | A1. not applicable - new lead B1. Redundant - no longer indicated B2A. Macrodisplacement B2B. Microdisplacement - high threshold/undersensing B6. Perforation B11. Oversensing - T wave B5. Oversensing - electromagnetic interference B4. Oversensing - myopotential E1. Suboptimal position - phrenic capture E3. Suboptimal position - dys-synchrony E4. Protrusion/discomfort/pre-erosion C4. Erosion/infection C3. Within planned surgical/radiotherapy D3. Lead problem - conductor fracture/high impedance  D2. Lead problem - insulation failure/low impedance B8. Lead problem - advisory/recall D4. Other
3.66 | [NAME] | BSI. Boston Scientific BTK. Biotronik ELA. Sorin ELA MED. Medtronic OSC. Oscor PAS. [NAME]. Sorin STK. Stoeckert VIT. [NAME] | Text (single value) | Current (2012/3) manufacturers shown in this list. For updates contact the NICOR CRM Database Coordinator. | BSI. Boston Scientific BTK. Biotronik ELA. Sorin ELA MED. Medtronic OSC. Oscor PAS. [NAME]. Sorin STK. Stoeckert VIT. [NAME]
3.67 | [NAME] | Valid model designation from relevant manufacturer | Text (single value) | No change
3.68 | Lead Serial Number LV2 | Free text | Text (single value) | No change
3.69 | Lead/Connector type LV2 | • IS1-bipolar • IS-1 unipolar • IS-4 • LV-1 • Other (specify in comments) |  |  | 1. IS1-bipolar 2. IS-1 unipolar 6. IS-4 7. LV-1 99. other
 | [NAME]Nonpacing) Defibrillation Lead 1 |  |  | Notes
3.7 | Lead Intervention DEFIB1 | • New DF lead  • Existing DF lead unaltered  • Additional DF lead  • DF lead replacement  • DF lead revision/reposition/reconnection  • DF lead removal  • No DF lead | Text (single value) | New field  If option 7 is selected no other fields need be completed. | 1. New DF lead 2. Existing DF lead unaltered 3. Additional DF lead 4. DF lead replacement 5. DF lead revision/reposition/reconnection 6. DF lead removal 7. No DF lead
3.71 | Location DEFIB1 | • RA/SVC/Innominate vein  • Coronary sinus  • Epicardial lead/patch  • Subcutaneous lead - anterior  • Subcutaneous lead -lateral/posterior  • Other (specify in comments) | Text (single value) | NEW FIELD | 1. RA/SVC/Innominate vein 2. Coronary sinus 3. Epicardial lead/patch 4. Subcutaneous lead - anterior 5. Subcutaneous lead -lateral/posterior 9. Other
3.72 | Main indication for new/additional (nonpacing) DEFIB1 lead | • N/A (not new/additional lead)  • subcutaneous defibrillator  • endocardial DFT inadequate  • Other (specify in comments) | Text (single value) | NEW FIELD | 1. not applicable - not new/additional lead 2. subcutaneous defibrillator 3. endocardial DFT inadequate 9. Other
3.73 | Main indication for replacement/revision/removal of [NAME] lead | • N/A (new/additional lead)  • Redundant (no longer indicated)  • Displacement  • Sensing problem  • Inadequate DFT  • Protrusion/discomfort/pre-erosion  • Erosion/infection  • Within surgical/radiotherapy field  • Lead problem - conductor fracture/high impedance  • Lead problem - insulation failure/low impedance  • Lead problem  - advisory/recall  • other (specify in comments) | Text (single value) | NEW FIELD | A1. not applicable - new/additional lead B1. Redundant - no longer indicated B2. Displacement B11. Sensing problem E2. Inadequate - DFT E4. Protrusion/discomfort/pre-erosion C4. Erosion/infection C3. Within planned surgical/radiotherapy D3. Lead problem - conductor fracture/high impedance  D2. Lead problem - insulation failure/low impedance B8. Lead problem - advisory/recall D4. Other
3.74 | [NAME] DEFIB1 | BSI. Boston Scientific BTK. Biotronik MED. Medtronic PAS. [NAME]. Sorin VIT. [NAME] | Text (single value) | Current (2012/3) manufacturers shown in this list. For updates contact the NICOR CRM Database Coordinator. | BSI. Boston Scientific BTK. Biotronik MED. Medtronic PAS. [NAME]. Sorin VIT. [NAME]
3.75 | [NAME] | Valid model designation from relevant manufacturer | Text (single value)
3.76 | Lead Serial Number DEFIB1 | Free text | Text (single value)
3.77 | Lead/Connector type [NAME] | • DF-1  • [NAME] inline tripolar • Other (specify in comments) |  |  | 1. DF-1  2. [NAME] inline tripolar 9. Other
 | [NAME]nonpacing) Defibrillation Lead 2
3.78 | Lead Intervention DEFIB2 | • New DF lead  • Existing DF lead unaltered  • Additional DF lead  • DF lead replacement  • DF lead revision/reposition/reconnection  • DF lead removal  • No DF lead | Text (single value) | New field  If option 7 is selected no other fields need be completed. | 1. New DF lead 2. Existing DF lead unaltered 3. Additional DF lead 4. DF lead replacement 5. DF lead revision/reposition/reconnection 6. DF lead removal 7. No DF lead
3.79 | Location DEFIB2 | • RA/SVC/Innominate vein  • Coronary sinus  • Epicardial lead/patch  • Subcutaneous lead - anterior  • Subcutaneous lead -lateral/posterior  • Other (specify in comments) | Text (single value) | NEW FIELD | 1. RA/SVC/Innominate vein 2. Coronary sinus 3. Epicardial lead/patch 4. Subcutaneous lead - anterior 5. Subcutaneous lead -lateral/posterior 9. Other
3.8 | Main indication for new/additional (nonpacing) DEFIB2 lead | • N/A (not new/additional lead)  • subcutaneous defibrillator  • endocardial DFT inadequate  • Other (specify in comments) | Text (single value) | NEW FIELD | 1. not applicable - not new/additional lead 2. subcutaneous defibrillator 3. endocardial DFT inadequate 9. Other
3.81 | Main indication for replacement/revision/removal of DEFIB2 lead | • N/A (new/additional lead)  • Redundant (no longer indicated)  • Displacement  • Sensing problem  • Inadequate DFT  • Protrusion/discomfort/pre-erosion  • Erosion/infection  • Within surgical/radiotherapy field  • Lead problem - conductor fracture/high impedance  • Lead problem - insulation failure/low impedance  • Lead problem  - advisory/recall  • other (specify in comments) | Text (single value) | NEW FIELD | A1. not applicable - new/additional lead B1. Redundant - no longer indicated B2. Displacement B11. Sensing problem E2. Inadequate - DFT E4. Protrusion/discomfort/pre-erosion C4. Erosion/infection C3. Within planned surgical/radiotherapy D3. Lead problem - conductor fracture/high impedance  D2. Lead problem - insulation failure/low impedance B8. Lead problem - advisory/recall D4. Other
3.82 | [NAME] DEFIB2 | BSI. Boston Scientific BTK. Biotronik ELA. Sorin ELA MED. Medtronic OSC. Oscor PAS. [NAME]. Sorin STK. Stoeckert VIT. [NAME] | Text (single value) | Current (2012/3) manufacturers shown in this list. For updates contact the NICOR CRM Database Coordinator. | BSI. Boston Scientific BTK. Biotronik ELA. Sorin ELA MED. Medtronic OSC. Oscor PAS. [NAME]. Sorin STK. Stoeckert VIT. [NAME]
3.83 | [NAME] | Valid model designation from relevant manufacturer | Text (single value)
3.84 | Lead Serial Number DEFIB2 | Free text | Text (single value)
3.85 | Lead/Connector type DEFIB2 | • DF-1  • [NAME] inline tripolar • Other (specify in comments) |  |  | 1. DF-1  2. [NAME] inline tripolar 9. Other
 | SECTION 4: LEAD EXTRACTION (other than by simple traction without locking stylet)
4.01 | Indication for lead extraction | • infection - apparently pocket/superficial only  • infection - bacteraemia/endocarditis  • Access (redundant lead(s))  • lead failure/fracture  • advisory/recall without malfunction yet  • other (specify in comments) |  | NEW FIELD | 1. infection - apparently pocket/superficial only 2. infection - bacteraemia/endocarditis 3. access - redundant lead(s) 4. lead failure/fracture 5. advisory/recall without malfunction yet 9. other
4.02 | Methods used | • locking stylet   • cutting sheath  • rotating dissection sheath (Evolution)  • laser sheath  • electrodissection sheath  • basket/snare  • thoracotomy | Text (multivalue ; separated) | NEW FIELD | 1. locking stylet  2. cutting sheath 3. rotating dissection sheath 4. laser sheath 5. electrodissection sheath 6. basket/snare 7. thoracotomy
4.03 | Number of pacing leads removed completely |  | Numeric | NEW FIELD
4.04 | Number of pacing leads removed partially |  | Numeric | NEW FIELD
4.05 | Number of coronary sinus leads removed completely |  | Numeric | NEW FIELD
4.06 | Number of coronary sinus leads removed partially |  | Numeric | NEW FIELD
4.07 | Number of DF leads removed completely |  | Numeric | NEW FIELD
4.08 | Number of DF leads removed partially |  | Numeric | NEW FIELD
 | SECTION 5: COMPLICATIONS |  | NEW
5.01 | Acute complications | • None  • RV lead displacement/loss of function requiring revision  • RA lead displacement/loss of function requiring revision  • LV lead displacement/loss of function requiring revision  • DF lead displacement/loss of function requiring revision  • Pneumothorax  • Haemothorax  • Haematoma  • Other wound problem  • Pericardial effusion/tamponade  • Intrathoracic bleed etc requiring thoracotomy or sternotomy  • Infection  • Death - procedure related  • Death - not procedure related  • Other (specify in comments) | multivalue | When to report? Report complications that arose during implant hospitalization (even if detected shortly after, e.g. first check after daycase implant or in first few days post discharge).  Which complications to report? Any that required intervention (including transfusion, aspiration/drain of pneumothorax or pericardial effusion) or  that delayed hospital discharge or required readmission. | 0. None 7A. RV lead displacement/loss of function requiring revision 7B. RA lead displacement/loss of function requiring revision 7C. LV lead displacement/loss of function requiring revision 7D. DF lead displacement/loss of function requiring revision 1. Pneumothorax 8. Haemothorax 4. Haematoma 10. Other wound problem 9. Pericardial effusion/tamponade 11. Intrathoracic bleed requiring thoracotomy/sternotomy 12. Infection 13. Death - procedure related 14. Death - not procedure related 99. Other
5.02 | Late complications | • None  • RV lead displacement/loss of function requiring revision  • RA lead displacement/loss of function requiring revision  • LV lead displacement/loss of function requiring revision  • DF lead displacement/loss of function requiring revision  • Haematoma  • Other wound problem  • Infection  • Death - procedure related  • Death - not procedure related  • Other (specify in comments) | multivalue | When to report? Any complications occurring between discharge and 1 year  (9-15 months acceptable)  Which complications to report? Any that required surgical intervention. NB: reintervention due to change of indication (eg upgrade) or advisory/recall is not to be reported as a complication | 0. None 7A. RV lead displacement/loss of function requiring revision 7B. RA lead displacement/loss of function requiring revision 7C. LV lead displacement/loss of function requiring revision 7D. DF lead displacement/loss of function requiring revision 4. Haematoma 10. Other wound problem 12. Infection 13. Death - procedure related 14. Death - not procedure related 99. Other
 | SECTION 6: FILE CLOSURE
6.01 | Date of file closure | Valid DateTime | Date (dd/mm/yyyy)
6.02 | Device File Closure | • Unspecified • Death Unrelated To Device • Death Related To Device • Death - Sudden • Death - Cause Unknown • Death - Lead Related • Non Cardiac Death • Cardiac Death Unrelated To ICD And Not Sudden • Death - Arrhythmic - ICD System Functioning • Operative Death • Other Death • Lost To Follow-Up • Hospital Transfer • Device Removed • Cardiac Transplant • Other Follow-Up • Shock therapies programmed off | Text (single value) |  | A1. Unspecified B1. Death Unrelated To Pacemaker B2. [NAME] B3. [NAME]. Death - Cause Unknown B5. Death - Lead Related B6. Non Cardiac Death B7. Cardiac Death Unrelated To ICD And Not Sudden B8. Death - Arrhythmic - ICD System Functioning B9. Operative Death B10. Other Death C1. Lost To Follow-Up C2. [NAME]. Pacemaker Removed C4. Cardiac Transplant C5. Other Follow-Up C6. Shock [NAME] Off