Psychological Distress in Patients with ICD Recall

Background: Multiple clinical trials have shown that a properly functioning implantable cardioverter‐defibrillator (ICD) is capable of interrupting sudden death caused by ventricular tachyarrhythmias. However, ICDs are complex medical devices, and they do not always perform as expected or they may fail completely. Exposure of ICD recipients to professional or media reports that their specific device type is potentially malfunctioning could negatively influence their psychological status.

[1]  W. Maisel,et al.  Pacemaker and ICD generator malfunctions: analysis of Food and Drug Administration annual reports. , 2006, JAMA.

[2]  E. Sigurdsson,et al.  Health-related quality of life of patients with implantable cardioverter defibrillators compared with that of pacemaker recipients. , 2006, Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology.

[3]  Robert G. Hauser,et al.  Lessons From the Failure and Recall of an Implantable Cardioverter-Defibrillator , 2005, Circulation.

[4]  J. Burkhardt,et al.  Malfunctions in implantable cardiac devices: putting the risk in perspective. , 2005, Cleveland Clinic journal of medicine.

[5]  W. Maisel Safety issues involving medical devices: implications of recent implantable cardioverter-defibrillator malfunctions. , 2005, JAMA.

[6]  R. Hauser,et al.  Deaths associated with implantable cardioverter defibrillator failure and deactivation reported in the United States Food and Drug Administration Manufacturer and User Facility Device Experience Database. , 2004, Heart rhythm.

[7]  A. Wase Random Internal Component Failure of an Implantable Cardioverter Defibrillator , 2004, Journal of Interventional Cardiac Electrophysiology.

[8]  W. Stevenson,et al.  Recalls and safety alerts involving pacemakers and implantable cardioverter-defibrillator generators. , 2001, JAMA.

[9]  D. Cannom,et al.  ICD Product Reliability: Lessons from Electrical Overstress Failures , 2001, Pacing and clinical electrophysiology : PACE.

[10]  V. Parsonnet,et al.  Unexpected ICD Pulse Generator Failure Due to Electronic Circuit Damage Caused by Electrical Overstress , 2001, Pacing and clinical electrophysiology : PACE.

[11]  J. Bourke,et al.  Florid psychopathology in patients receiving shocks from implanted cardioverter-defibrillators , 1997, Heart.

[12]  M. Hegel,et al.  Anxiety and Depression in Patients Receiving Implanted Cardioverter-Defibrillators: A Longitudinal Investigation , 1997, International journal of psychiatry in medicine.