Complications Associated with Generator Replacement, a Single Center Experience

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Introduction: Device recalls create problems for patients and physicians. Need for evidence-based recommendations regarding management of patients with advisory devices has been highlighted. Methods: We reviewed generator changes performed between 2009 and 2010 at Fuwai Hospital, including a total of 485 patients who underwent pacemaker replacement. Complications included major and minor complications. Major complications included postoperative death, MI after operation, infection requiring system extraction, pocket hematoma requiring drainage, pocket revision, and lead damage/malfunction after implantation. Minor complications were defined as events that necessitated close follow-up or change in treatment but did not require operative intervention. Results: Totally there were 5 major complications (1.03%), including 1 infection requiring system extraction, 3 pocket hematoma requiring drainage, and 1 lead damage. 6 minor complications (1.23%) were occured, including 4 minor hematoma, 1 pneumothorax during operation, and 1 lower limb arteriovenous fistula. Conclusions: Even with experienced operators complications can occur when replacing generators for adevice recall. We need do more works for risk assessment of device replacement.