Complication risk with pulse generator change: Implications when reacting to a device advisory or recall

Suraj Kapa, Linda Hyberger, Robert F. Rea, David L. Hayes

Research output: Contribution to journalReview articlepeer-review

47 Scopus citations


Background: Recent advisories and recalls of pacemakers and implantable cardioverter-defibrillators (ICDs) have highlighted the need for evidence-based recommendations regarding management of patients with advisory devices. In order to better facilitate decision-making when weighing the relative risks and benefits of performing generator changes in these patients, we conducted a review to assess operative complication rates. Methods: We reviewed generator changes performed between 2000 and 2005 at the Mayo Clinic-Rochester, including a total of 732 change-outs consisting of 570 done for elective replacement indicators (ERI) and 162 for manufacturer advisories or recalls. Complications included all those requiring reoperation, occurring within a 60-day period postoperatively and directly attributable to the generator change. These included infection requiring device excision, hematoma requiring evacuation, and incisional dehiscence requiring reclosure. Results: Operation-associated complications requiring intervention were noted in 9 patients, or 1.24% of our population. Of these nine complications, eight occurred among patients receiving pulse generator replacement for ERI (1.40%) and one occurred in a patient receiving replacement for a manufacturer advisory or recall (0.62%). Complications included 5 infections, 3 hematomas, and 1 incisional dehiscence. Conclusions: Generator replacement is not a benign procedure and associated risks must be weighed in the context of other variables when making management choices in patients with advisory or recall devices.

Original languageEnglish (US)
Pages (from-to)730-733
Number of pages4
JournalPACE - Pacing and Clinical Electrophysiology
Issue number6
StatePublished - Jun 2007


  • Device advisory
  • Device recall
  • Operative risk
  • Pulse generator change

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine


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