Fatal complications of pacemaker and implantable cardioverter-defibrillator implantation: medical malpractice?

Objective: Pacemaker implantation has become a routine procedure in modern cardiology, and implantable cardioverter-defibrillators are implanted with rising frequency. Although fatal complications are relatively rare, they may give rise to malpractice lawsuits against medical personnel. The objective was to identify fatal complications after pacemaker and implantable cardioverter-defibrillators implantation and to evaluate the legal consequences in alleged malpractice cases. Methods: Retrospective analysis of all 27,730 autopsy cases performed at the Institute of Legal Medicine, Hamburg, Germany, between January 1983 and June 2007. Study cases were identified using the keywords ‘cardiac death’, ‘malpractice’, ‘complications’, ‘pacemaker’ and ‘implantable cardioverter-defibrillator’. Results: Eleven pacemakerrelated and four implantable cardioverter-defibrillator-related fatalities where lawsuits had been filed were identified. A causal connection between the procedure and fatal outcome was confirmed by autopsy in six cases. Malpractice or violation of the rules of good medical practice could be excluded in all cases. All inquiries were abandoned. Conclusion: Fatal complications after pacemaker and implantable cardioverter-defibrillator implantation attributable to medical malpractice are extremely rare. The study illustrates the importance of a medico-legal autopsy in alleged fatal malpractice cases. 2009 Published by European Association for Cardio-Thoracic Surgery. All rights reserved.