Pacemaker Malfunction
- Author: Chakri Yarlagadda, MD, FACC, FASNC, FSCAI; Chief Editor: Jeffrey N Rottman, MD more...
Background
The number of pacemaker implants is growing because of newer indications. There are a few million pacemaker patients worldwide with hundreds of thousands of new implants yearly. Knowledge of different modes, timing cycles, and event markers, as well as newer algorithms, is necessary for accurate diagnosis of pacing system malfunction.
Pathophysiology
Although true pulse generator failure is very rare, pacing system malfunction occurs occasionally. Pacing system malfunction can be due to malfunction of lead, electrode-tissue interface, or pulse generator. Most of these malfunctions can be corrected by simple reprogramming of the device. The majority of malfunctions in fact are due to normal programmed pacemaker function. Thorough understanding of the cause of malfunction is extremely important for accurate diagnosis and management.
Epidemiology
Frequency
United States
Maisel reported pacemaker generator failure rate of 0.46% based on US FDA reports and 1.3 malfunctions per 1000 person-years based on device registries.[1, 2] Actual incidence of pacemaker malfunction, however, would be higher since these numbers are exclusive of lead failure. Hauser et al reported a 2% device electronic failure rate at their center.[3]
International
Actual incidence of pacemaker malfunction is unknown.
Mortality/Morbidity
Overall morbidity and mortality depend on the underlying cause of malfunction as well as the patient's dependency on the pacemaker. Most pacing system malfunctions are benign, although conditions such as cross-talk inhibition or runaway pacemaker can be life threatening. Maisel reported a 1 in 75,000 death rate among pacer implants.[2]
Maisel WH, Moynahan M, Zuckerman BD, Gross TP, Tovar OH, Tillman DB. Pacemaker and ICD generator malfunctions: analysis of Food and Drug Administration annual reports. JAMA. Apr 26 2006;295(16):1901-6. [Medline].
Maisel WH. Pacemaker and ICD generator reliability: meta-analysis of device registries. JAMA. Apr 26 2006;295(16):1929-34. [Medline].
Hauser RG, Hayes DL, Kallinen LM, Cannom DS, Epstein AE, Almquist AK, et al. Clinical experience with pacemaker pulse generators and transvenous leads: an 8-year prospective multicenter study. Heart Rhythm. Feb 2007;4(2):154-60. [Medline].
Amin MS, Matchar DB, Wood MA, Ellenbogen KA. Management of recalled pacemakers and implantable cardioverter-defibrillators: a decision analysis model. JAMA. Jul 26 2006;296(4):412-20. [Medline].
Johansen JB, Jorgensen OD, Moller M, et al. Infection after pacemaker implantation: infection rates and risk factors associated with infection in a population-based cohort study of 46299 consecutive patients. Eur Heart J. Apr 2011;32(8):991-8. [Medline]. [Full Text].
Erickson S, Sweesy M, Forney R. Complications and Corrections in Pacing systems. Pacing Clin Electrophysiol. 1995;18:99-1004.
Földesi C, Hegedüs Z, Simon J, Pap I, Rudas L. [Pacemaker syndrome without a pacemaker]. Orv Hetil. Aug 30 1998;139(35):2081-2. [Medline].
Goldman DS, Levine PA. Pacemaker-mediated polymorphic ventricular tachycardia. Pacing Clin Electrophysiol. Oct 1998;21(10):1993-5. [Medline].
Heldman D, Mulvihill D, Nguyen H, Messenger JC, Rylaarsdam A, Evans K. True incidence of pacemaker syndrome. Pacing Clin Electrophysiol. Dec 1990;13(12 Pt 2):1742-50. [Medline].
Levine PA, Love CJ. Pacemaker diagnostics and evaluation of pacing system malfunction. In: Clinical Cardiac Pacing and Defibrillation. 2nd ed. Philadelphia, Pa: WB Saunders; 2000:827-875.
Pinski SL, Trohman RG. Interference with cardiac pacing. Cardiol Clin. Feb 2000;18(1):219-39, x. [Medline].
Sweesy MW, Holland JL. Pseudomalfunction. In: Cardiac Device and Basic EP-Self Assessment. Simpsonville, SC: Cardiac Device Consultants, Inc; 2000:60-86.
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