Official reprint from UpToDate®
www.uptodate.com ©2016 UpToDate®

Implantable cardioverter-defibrillators: Complications

Leonard I Ganz, MD, FHRS, FACC
Section Editor
Brian Olshansky, MD
Deputy Editor
Brian C Downey, MD, FACC


The implantable cardioverter-defibrillator (ICD) is highly effective in terminating ventricular tachyarrhythmias, including ventricular tachycardia (VT) and ventricular fibrillation (VF), thereby aborting sudden cardiac death (SCD). ICD use has been associated with improved survival due to fewer arrhythmic deaths, when compared to antiarrhythmic drugs in survivors of sudden cardiac death (SCD). There is also evidence of benefit when used for primary prevention in selected groups of patients. (See "Secondary prevention of sudden cardiac death in heart failure and cardiomyopathy" and "Primary prevention of sudden cardiac death in heart failure and cardiomyopathy", section on 'Use of an ICD' and "Primary prevention of sudden cardiac death in heart failure and cardiomyopathy".)

There are a variety of potential complications associated with ICD use [1]. However, the rate of complications related to the ICD has fallen markedly with the evolution from a large device that required an abdominal pocket and insertion of an epicardial lead system via thoracotomy to the current use of much smaller transvenous pectoral devices [2,3]. In one report, the incidence of complications with nonthoracotomy ICDs was significantly lower with a pectoral compared to an abdominal generator site (6 versus 13 percent) [2].

Complications associated with an ICD will be reviewed here. The general principles of the ICD, and recommendations for ICD use, are discussed separately. (See "General principles of the implantable cardioverter-defibrillator" and "Secondary prevention of sudden cardiac death in heart failure and cardiomyopathy", section on 'Our approach' and "Primary prevention of sudden cardiac death in heart failure and cardiomyopathy".)


The exact incidence of ICD malfunction is difficult to determine due to inconsistent definitions and the lack of mandatory reporting. Information comes from small observational studies, as well as from annual reports filed with the United States Food and Drug Administration by companies that make devices and from voluntary registries [4-6]. The latter sources generally include device malfunctions severe enough to require explantation.

The incidence of a broad list of major and minor complications was illustrated in a prospective study of 778 patients receiving a transvenous ICD. The rate of freedom from any adverse event at 1, 3, and 12 months was 79, 68, and 51 percent, respectively [4]. Among the complications that occurred, 60 percent were due to the ICD system, 29 percent were related to the implantation procedure, and 11 percent were not device related. The most common events were inappropriate detection and subsequent delivery of a shock (16 percent), which usually resolved with device reprogramming or drug readjustment, wound/pocket problems (4 percent) and lead/ICD can dislodgement or migration (3 percent).


Subscribers log in here

To continue reading this article, you must log in with your personal, hospital, or group practice subscription. For more information or to purchase a personal subscription, click below on the option that best describes you:
Literature review current through: Nov 2016. | This topic last updated: Fri Mar 04 00:00:00 GMT+00:00 2016.
The content on the UpToDate website is not intended nor recommended as a substitute for medical advice, diagnosis, or treatment. Always seek the advice of your own physician or other qualified health care professional regarding any medical questions or conditions. The use of this website is governed by the UpToDate Terms of Use ©2016 UpToDate, Inc.
  1. Pfeiffer D, Jung W, Fehske W, et al. Complications of pacemaker-defibrillator devices: diagnosis and management. Am Heart J 1994; 127:1073.
  2. Kron J, Herre J, Renfroe EG, et al. Lead- and device-related complications in the antiarrhythmics versus implantable defibrillators trial. Am Heart J 2001; 141:92.
  3. DiMarco JP. Implantable cardioverter-defibrillators. N Engl J Med 2003; 349:1836.
  4. Rosenqvist M, Beyer T, Block M, et al. Adverse events with transvenous implantable cardioverter-defibrillators: a prospective multicenter study. European 7219 Jewel ICD investigators. Circulation 1998; 98:663.
  5. Maisel WH, Moynahan M, Zuckerman BD, et al. Pacemaker and ICD generator malfunctions: analysis of Food and Drug Administration annual reports. JAMA 2006; 295:1901.
  6. Maisel WH. Pacemaker and ICD generator reliability: meta-analysis of device registries. JAMA 2006; 295:1929.
  7. Kuck KH, Cappato R, Siebels J, Rüppel R. Randomized comparison of antiarrhythmic drug therapy with implantable defibrillators in patients resuscitated from cardiac arrest : the Cardiac Arrest Study Hamburg (CASH). Circulation 2000; 102:748.
  8. Atwater BD, Daubert JP. Implantable cardioverter defibrillators: risks accompany the life-saving benefits. Heart 2012; 98:764.
  9. Dodson JA, Lampert R, Wang Y, et al. Temporal trends in quality of care among recipients of implantable cardioverter-defibrillators: insights from the National Cardiovascular Data Registry. Circulation 2014; 129:580.
  10. Russo AM, Daugherty SL, Masoudi FA, et al. Gender and outcomes after primary prevention implantable cardioverter-defibrillator implantation: Findings from the National Cardiovascular Data Registry (NCDR). Am Heart J 2015; 170:330.
  11. Dewland TA, Pellegrini CN, Wang Y, et al. Dual-chamber implantable cardioverter-defibrillator selection is associated with increased complication rates and mortality among patients enrolled in the NCDR implantable cardioverter-defibrillator registry. J Am Coll Cardiol 2011; 58:1007.
  12. van Rees JB, de Bie MK, Thijssen J, et al. Implantation-related complications of implantable cardioverter-defibrillators and cardiac resynchronization therapy devices: a systematic review of randomized clinical trials. J Am Coll Cardiol 2011; 58:995.
  13. Freeman JV, Wang Y, Curtis JP, et al. Physician procedure volume and complications of cardioverter-defibrillator implantation. Circulation 2012; 125:57.
  14. Swindle JP, Rich MW, McCann P, et al. Implantable cardiac device procedures in older patients: use and in-hospital outcomes. Arch Intern Med 2010; 170:631.
  15. Hsu JC, Varosy PD, Bao H, et al. Cardiac perforation from implantable cardioverter-defibrillator lead placement: insights from the national cardiovascular data registry. Circ Cardiovasc Qual Outcomes 2013; 6:582.
  16. Migliore F, Zorzi A, Bertaglia E, et al. Incidence, management, and prevention of right ventricular perforation by pacemaker and implantable cardioverter defibrillator leads. Pacing Clin Electrophysiol 2014; 37:1602.
  17. Al-Khatib SM, Lucas FL, Jollis JG, et al. The relation between patients' outcomes and the volume of cardioverter-defibrillator implantation procedures performed by physicians treating Medicare beneficiaries. J Am Coll Cardiol 2005; 46:1536.
  18. Curtis JP, Luebbert JJ, Wang Y, et al. Association of physician certification and outcomes among patients receiving an implantable cardioverter-defibrillator. JAMA 2009; 301:1661.
  19. Bernard ML, Shotwell M, Nietert PJ, Gold MR. Meta-analysis of bleeding complications associated with cardiac rhythm device implantation. Circ Arrhythm Electrophysiol 2012; 5:468.
  20. Birnie DH, Healey JS, Wells GA, et al. Pacemaker or defibrillator surgery without interruption of anticoagulation. N Engl J Med 2013; 368:2084.
  21. Du L, Zhang Y, Wang W, Hou Y. Perioperative anticoagulation management in patients on chronic oral anticoagulant therapy undergoing cardiac devices implantation: a meta-analysis. Pacing Clin Electrophysiol 2014; 37:1573.
  22. Sant'anna RT, Leiria TL, Nascimento T, et al. Meta-analysis of continuous oral anticoagulants versus heparin bridging in patients undergoing CIED surgery: reappraisal after the BRUISE study. Pacing Clin Electrophysiol 2015; 38:417.
  23. Jennings JM, Robichaux R, McElderry HT, et al. Cardiovascular implantable electronic device implantation with uninterrupted dabigatran: comparison to uninterrupted warfarin. J Cardiovasc Electrophysiol 2013; 24:1125.
  24. Rowley CP, Bernard ML, Brabham WW, et al. Safety of continuous anticoagulation with dabigatran during implantation of cardiac rhythm devices. Am J Cardiol 2013; 111:1165.
  25. Kosiuk J, Koutalas E, Doering M, et al. Treatment with novel oral anticoagulants in a real-world cohort of patients undergoing cardiac rhythm device implantations. Europace 2014; 16:1028.
  26. Prutkin JM, Reynolds MR, Bao H, et al. Rates of and factors associated with infection in 200 909 Medicare implantable cardioverter-defibrillator implants: results from the National Cardiovascular Data Registry. Circulation 2014; 130:1037.
  27. Guha A, Maddox WR, Colombo R, et al. Cardiac implantable electronic device infection in patients with end-stage renal disease. Heart Rhythm 2015; 12:2395.
  28. Poole JE, Gleva MJ, Mela T, et al. Complication rates associated with pacemaker or implantable cardioverter-defibrillator generator replacements and upgrade procedures: results from the REPLACE registry. Circulation 2010; 122:1553.
  29. Chung MK, Holcomb RG, Mittal S, et al. REPLACE DARE (Death After Replacement Evaluation) score: determinants of all-cause mortality after implantable device replacement or upgrade from the REPLACE registry. Circ Arrhythm Electrophysiol 2014; 7:1048.
  30. Gould PA, Krahn AD, Canadian Heart Rhythm Society Working Group on Device Advisories. Complications associated with implantable cardioverter-defibrillator replacement in response to device advisories. JAMA 2006; 295:1907.
  31. Mehta D, Nayak HM, Singson M, et al. Late complications in patients with pectoral defibrillator implants with transvenous defibrillator lead systems: high incidence of insulation breakdown. Pacing Clin Electrophysiol 1998; 21:1893.
  32. Zuber M, Huber P, Fricker U, et al. Assessment of the subclavian vein in patients with transvenous pacemaker leads. Pacing Clin Electrophysiol 1998; 21:2621.
  33. Eckstein J, Koller MT, Zabel M, et al. Necessity for surgical revision of defibrillator leads implanted long-term: causes and management. Circulation 2008; 117:2727.
  34. Maisel WH, Kramer DB. Implantable cardioverter-defibrillator lead performance. Circulation 2008; 117:2721.
  35. Ellenbogen KA, Wood MA, Shepard RK, et al. Detection and management of an implantable cardioverter defibrillator lead failure: incidence and clinical implications. J Am Coll Cardiol 2003; 41:73.
  36. Kleemann T, Becker T, Doenges K, et al. Annual rate of transvenous defibrillation lead defects in implantable cardioverter-defibrillators over a period of >10 years. Circulation 2007; 115:2474.
  37. Hauser RG, Kallinen LM, Almquist AK, et al. Early failure of a small-diameter high-voltage implantable cardioverter-defibrillator lead. Heart Rhythm 2007; 4:892.
  38. Kallinen LM, Hauser RG, Lee KW, et al. Failure of impedance monitoring to prevent adverse clinical events caused by fracture of a recalled high-voltage implantable cardioverter-defibrillator lead. Heart Rhythm 2008; 5:775.
  39. van Rees JB, van Welsenes GH, Borleffs CJ, et al. Update on small-diameter implantable cardioverter-defibrillator leads performance. Pacing Clin Electrophysiol 2012; 35:652.
  40. Groves R. Urgent medical device information. Medtronic, Inc. October 15, 2007.
  41. Hauser RG, Abdelhadi R, McGriff D, Retel LK. Deaths caused by the failure of Riata and Riata ST implantable cardioverter-defibrillator leads. Heart Rhythm 2012; 9:1227.
  42. Gunderson BD, Patel AS, Bounds CA, et al. An algorithm to predict implantable cardioverter-defibrillator lead failure. J Am Coll Cardiol 2004; 44:1898.
  43. Swerdlow CD, Gunderson BD, Ousdigian KT, et al. Downloadable algorithm to reduce inappropriate shocks caused by fractures of implantable cardioverter-defibrillator leads. Circulation 2008; 118:2122.
  44. Lin G, Nishimura RA, Connolly HM, et al. Severe symptomatic tricuspid valve regurgitation due to permanent pacemaker or implantable cardioverter-defibrillator leads. J Am Coll Cardiol 2005; 45:1672.
  45. Delling FN, Hassan ZK, Piatkowski G, et al. Tricuspid Regurgitation and Mortality in Patients With Transvenous Permanent Pacemaker Leads. Am J Cardiol 2016; 117:988.
  46. Eleid MF, Blauwet LA, Cha YM, et al. Bioprosthetic tricuspid valve regurgitation associated with pacemaker or defibrillator lead implantation. J Am Coll Cardiol 2012; 59:813.
  47. Maisel WH, Sweeney MO, Stevenson WG, et al. Recalls and safety alerts involving pacemakers and implantable cardioverter-defibrillator generators. JAMA 2001; 286:793.
  48. Korte T, Jung W, Schlippert U, et al. Prospective evaluation of shoulder-related problems in patients with pectoral cardioverter-defibrillator implantation. Am Heart J 1998; 135:577.
  49. Chaara J, Sunthorn H. Twiddler syndrome. J Cardiovasc Electrophysiol 2014; 25:659.
  50. Boyle NG, Anselme F, Monahan KM, et al. Twiddler's syndrome variants in ICD patients. Pacing Clin Electrophysiol 1998; 21:2685.
  51. Carnero-Varo A, Pérez-Paredes M, Ruiz-Ros JA, et al. "Reel Syndrome": a new form of Twiddler's syndrome? Circulation 1999; 100:e45.
  52. Gould PA, Gula LJ, Champagne J, et al. Outcome of advisory implantable cardioverter-defibrillator replacement: one-year follow-up. Heart Rhythm 2008; 5:1675.
  53. Hauser RG, Hayes DL, Almquist AK, et al. Unexpected ICD pulse generator failure due to electronic circuit damage caused by electrical overstress. Pacing Clin Electrophysiol 2001; 24:1046.
  54. Germano JJ, Reynolds M, Essebag V, Josephson ME. Frequency and causes of implantable cardioverter-defibrillator therapies: is device therapy proarrhythmic? Am J Cardiol 2006; 97:1255.
  55. Klein RC, Raitt MH, Wilkoff BL, et al. Analysis of implantable cardioverter defibrillator therapy in the Antiarrhythmics Versus Implantable Defibrillators (AVID) Trial. J Cardiovasc Electrophysiol 2003; 14:940.
  56. Dichtl W, Wolber T, Paoli U, et al. Appropriate therapy but not inappropriate shocks predict survival in implantable cardioverter defibrillator patients. Clin Cardiol 2011; 34:433.
  57. Daubert JP, Zareba W, Cannom DS, et al. Inappropriate implantable cardioverter-defibrillator shocks in MADIT II: frequency, mechanisms, predictors, and survival impact. J Am Coll Cardiol 2008; 51:1357.
  58. Saxon LA, Hayes DL, Gilliam FR, et al. Long-term outcome after ICD and CRT implantation and influence of remote device follow-up: the ALTITUDE survival study. Circulation 2010; 122:2359.
  59. Poole JE, Johnson GW, Hellkamp AS, et al. Prognostic importance of defibrillator shocks in patients with heart failure. N Engl J Med 2008; 359:1009.
  60. Powell BD, Saxon LA, Boehmer JP, et al. Survival after shock therapy in implantable cardioverter-defibrillator and cardiac resynchronization therapy-defibrillator recipients according to rhythm shocked. The ALTITUDE survival by rhythm study. J Am Coll Cardiol 2013; 62:1674.
  61. van Rees JB, Borleffs CJ, de Bie MK, et al. Inappropriate implantable cardioverter-defibrillator shocks: incidence, predictors, and impact on mortality. J Am Coll Cardiol 2011; 57:556.
  62. Moss AJ, Schuger C, Beck CA, et al. Reduction in inappropriate therapy and mortality through ICD programming. N Engl J Med 2012; 367:2275.
  63. Friedman PA, McClelland RL, Bamlet WR, et al. Dual-chamber versus single-chamber detection enhancements for implantable defibrillator rhythm diagnosis: the detect supraventricular tachycardia study. Circulation 2006; 113:2871.
  64. Friedman PA, Bradley D, Koestler C, et al. A prospective randomized trial of single- or dual-chamber implantable cardioverter-defibrillators to minimize inappropriate shock risk in primary sudden cardiac death prevention. Europace 2014; 16:1460.
  65. Berg SK, Moons P, Zwisler AD, et al. Phantom shocks in patients with implantable cardioverter defibrillator: results from a randomized rehabilitation trial (COPE-ICD). Europace 2013; 15:1463.
  66. Prudente LA, Reigle J, Bourguignon C, et al. Psychological indices and phantom shocks in patients with ICD. J Interv Card Electrophysiol 2006; 15:185.
  67. Jacob S, Panaich SS, Zalawadiya SK, et al. Phantom shocks unmasked: clinical data and proposed mechanism of memory reactivation of past traumatic shocks in patients with implantable cardioverter defibrillators. J Interv Card Electrophysiol 2012; 34:205.
  68. Wathen MS, DeGroot PJ, Sweeney MO, et al. Prospective randomized multicenter trial of empirical antitachycardia pacing versus shocks for spontaneous rapid ventricular tachycardia in patients with implantable cardioverter-defibrillators: Pacing Fast Ventricular Tachycardia Reduces Shock Therapies (PainFREE Rx II) trial results. Circulation 2004; 110:2591.
  69. Wathen MS, Sweeney MO, DeGroot PJ, et al. Shock reduction using antitachycardia pacing for spontaneous rapid ventricular tachycardia in patients with coronary artery disease. Circulation 2001; 104:796.
  70. Wood MA, Stambler BS, Damiano RJ, et al. Lessons learned from data logging in a multicenter clinical trial using a late-generation implantable cardioverter-defibrillator. The Guardian ATP 4210 Multicenter Investigators Group. J Am Coll Cardiol 1994; 24:1692.
  71. Schaumann A, von zur Mühlen F, Herse B, et al. Empirical versus tested antitachycardia pacing in implantable cardioverter defibrillators: a prospective study including 200 patients. Circulation 1998; 97:66.
  72. Steinberg JS, Martins J, Sadanandan S, et al. Antiarrhythmic drug use in the implantable defibrillator arm of the Antiarrhythmics Versus Implantable Defibrillators (AVID) Study. Am Heart J 2001; 142:520.
  73. Böcker D, Block M, Isbruch F, et al. Comparison of frequency of aggravation of ventricular tachyarrhythmias after implantation of automatic defibrillators using epicardial versus nonthoracotomy lead systems. Am J Cardiol 1993; 71:1064.
  74. Sweeney MO, Ruetz LL, Belk P, et al. Bradycardia pacing-induced short-long-short sequences at the onset of ventricular tachyarrhythmias: a possible mechanism of proarrhythmia? J Am Coll Cardiol 2007; 50:614.
  75. Florin TJ, Weiss DN, Peters RW, et al. Induction of atrial fibrillation with low-energy defibrillator shocks in patients with implantable cardioverter defibrillators. Am J Cardiol 1997; 80:960.
  76. Katz A, Sweeney RJ, Gill RM, et al. Relation of atrial refractoriness to upper and lower limits of vulnerability for atrial fibrillation/flutter following implantable ventricular defibrillator shocks. Circulation 1999; 100:1125.
  77. Epstein AE, Kay GN, Plumb VJ, et al. Gross and microscopic pathological changes associated with nonthoracotomy implantable defibrillator leads. Circulation 1998; 98:1517.
  78. Martin DT, John R, Venditti FJ Jr. Increase in defibrillation threshold in non-thoracotomy implantable defibrillators using a biphasic waveform. Am J Cardiol 1995; 76:263.
  79. Newman D, Barr A, Greene M, et al. A population-based method for the estimation of defibrillation energy requirements in humans. Assessment of time-dependent effects with a transvenous defibrillation system. Circulation 1997; 96:267.
  80. Rashba EJ, Olsovsky MR, Shorofsky SR, et al. Temporal decline in defibrillation thresholds with an active pectoral lead system. J Am Coll Cardiol 2001; 38:1150.
  81. Zhou L, Chen BP, Kluger J, et al. Effects of amiodarone and its active metabolite desethylamiodarone on the ventricular defibrillation threshold. J Am Coll Cardiol 1998; 31:1672.
  82. Goldschlager N, Epstein AE, Naccarelli G, et al. Practical guidelines for clinicians who treat patients with amiodarone. Practice Guidelines Subcommittee, North American Society of Pacing and Electrophysiology. Arch Intern Med 2000; 160:1741.
  83. Hohnloser SH, Dorian P, Roberts R, et al. Effect of amiodarone and sotalol on ventricular defibrillation threshold: the optimal pharmacological therapy in cardioverter defibrillator patients (OPTIC) trial. Circulation 2006; 114:104.
  84. Venditti FJ Jr, John RM, Hull M, et al. Circadian variation in defibrillation energy requirements. Circulation 1996; 94:1607.
  85. Luria D, Stanton MS, Eldar M, Glikson M. Pneumothorax: an unusual cause of ICD defibrillation failure. Pacing Clin Electrophysiol 1998; 21:474.
  86. Cohen TJ, Lowenkron DD. The effects of pneumothorax on defibrillation thresholds during pectoral implantation of an active can implantable cardioverter defibrillator. Pacing Clin Electrophysiol 1998; 21:468.
  87. Pinski SL, Trohman RG. Interference in implanted cardiac devices, Part I. Pacing Clin Electrophysiol 2002; 25:1367.
  88. Pinski SL, Trohman RG. Interference in implanted cardiac devices, part II. Pacing Clin Electrophysiol 2002; 25:1496.
  89. Ahmad M, Bloomstein L, Roelke M, et al. Patients' attitudes toward implanted defibrillator shocks. Pacing Clin Electrophysiol 2000; 23:934.
  90. Herrmann C, von zur Mühen F, Schaumann A, et al. Standardized assessment of psychological well-being and quality-of-life in patients with implanted defibrillators. Pacing Clin Electrophysiol 1997; 20:95.
  91. Sears SF, Todaro JF, Urizar G, et al. Assessing the psychosocial impact of the ICD: a national survey of implantable cardioverter defibrillator health care providers. Pacing Clin Electrophysiol 2000; 23:939.
  92. Burgess ES, Quigley JF, Moran G, et al. Predictors of psychosocial adjustment in patients with implantable cardioverter defibrillators. Pacing Clin Electrophysiol 1997; 20:1790.
  93. Schron EB, Exner DV, Yao Q, et al. Quality of life in the antiarrhythmics versus implantable defibrillators trial: impact of therapy and influence of adverse symptoms and defibrillator shocks. Circulation 2002; 105:589.
  94. Namerow PB, Firth BR, Heywood GM, et al. Quality-of-life six months after CABG surgery in patients randomized to ICD versus no ICD therapy: findings from the CABG Patch Trial. Pacing Clin Electrophysiol 1999; 22:1305.
  95. Passman R, Subacius H, Ruo B, et al. Implantable cardioverter defibrillators and quality of life: results from the defibrillators in nonischemic cardiomyopathy treatment evaluation study. Arch Intern Med 2007; 167:2226.
  96. Kamphuis HC, de Leeuw JR, Derksen R, et al. Implantable cardioverter defibrillator recipients: quality of life in recipients with and without ICD shock delivery: a prospective study. Europace 2003; 5:381.
  97. Bourke JP, Turkington D, Thomas G, et al. Florid psychopathology in patients receiving shocks from implanted cardioverter-defibrillators. Heart 1997; 78:581.
  98. Kohn CS, Petrucci RJ, Baessler C, et al. The effect of psychological intervention on patients' long-term adjustment to the ICD: a prospective study. Pacing Clin Electrophysiol 2000; 23:450.
  99. Tchou PJ, Piasecki E, Gutmann M, et al. Psychological support and psychiatric management of patients with automatic implantable cardioverter defibrillators. Int J Psychiatry Med 1989; 19:393.