title: Complication risk with pulse generator change: implications when reacting to a device advisory or recall.
abstract: 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.
authors.affiliation: Division of Cardiology, Mayo Clinic, Rochester, Minnesota 55905, USA.
authors.forename: Suraj
authors.initials: S
authors.lastname: Kapa
authors.forename: Linda
authors.initials: L
authors.lastname: Hyberger
authors.forename: Robert F
authors.initials: RF
authors.lastname: Rea
authors.forename: David L
authors.initials: DL
authors.lastname: Hayes
mesh_terms: D017147:Defibrillators, Implantable / Q000009:adverse effects*; D020878:Device Removal; D006801:Humans; D011475:Prosthesis Failure; D012086:Reoperation; D012189:Retrospective Studies; D012307:Risk Factors