Death as a complication of device implant | 0.37±0.48 | 0.77% (Circulation.1998;98:663–670); 2.08% (Br Heart J.1995:73:20–24) |
Lead dislodgement requiring lead repositioning | 3.5±2.08 | 5% (PACE.2005; 28:926–932); 10% (Circulation.1998;98:663–670) |
Lead failure requiring extraction or additional lead insertion | 5.4±7.28 | 4.3% (PACE.2005;28:926–932) |
Major haematoma requiring reoperation | 2.72±3.07 | 5.8% (JAMA.2006:295:1901–1911) |
Device infection requiring removal/extraction | 2.27±2.4 | 0.5% (PACE.2005:28:926–932); 0.77% (Circulation.1998;98:663–670);0.7% (MADIT2 trial) |
Cardiac tamponade | 0.7±1.07 | 0.2% (PACE.2005;28:926–932); 0.64% (Circulation.1998;98:663–670) |
Pneumothorax | 1.68±1.17 | 1.1% (PACE.2005; 28:926–932); 0.89% (Circulation.1998;98:663–670) |
Inappropriate shocks | 14.8±10.92 | 12% (PACE.2005; 28:926–932); 14.91% (Circulation.1998;98:663–670); 18% (Z Kardiol.1996;85:809–819) |
Psychological problems associated with the device | 22.6±26.68 | 13–38% (Clin Cardiol 1999;22:481–9) |