title: Impact of manufacturer advisories and FDA recalls of implantable cardioverter defibrillator generators in pediatric and congenital heart disease patients.
abstract: BACKGROUND
  Recalls of implantable cardioverter defibrillator (ICD) generators have affected many patients. No information is available regarding the impact specifically on pediatric and congenital heart disease (CHD) patients. This study was undertaken to determine implications of ICD manufacturers' advisories and recalls on children and CHD patients.
  
  
  METHODS
  The first part of this study involved single-center review of patients who underwent ICD placement between 2000 and 2005. Patients with ICDs affected by the 2005 advisories/recalls were reviewed for incidence of explantation, malfunction and complications. Secondly, members of the Pediatric and Congenital Electrophysiology Society (PACES) were queried for patients with affected devices, incidences of explantation, malfunction, and explant-related complications. Data were pooled for aggregate summary.
  
  
  RESULTS
  Among 233 patients who underwent ICD implantation at our institution during the study period, 58 (25%) patients had advisory/recalled devices and 13 of 58 (22%) underwent explantation following 3.1 +/- 1.3 years implant duration. No defects were identified by the manufacturer. No patients experienced complications requiring reintervention or rehospitalization. Questionnaire responses were received from 22 PACES institutions, included 177 patients with affected devices, of which 76 (43%) were removed. One patient died from complications following revision, and 1 patient had complications requiring reoperation. Two explanted devices had loose headers; no other defects were discovered. Taken together, 2 of 89 explanted devices were defective, and 2 complications occurred from explantation.
  
  
  CONCLUSIONS
  Advisories and recalls affect substantial numbers of pediatric and CHD patients. A significant proportion underwent explantation. Although complications are infrequent, there are important medical, psychosocial, and financial impacts associated with ICD replacement.
authors.affiliation: Children's Hospital Boston, Harvard Medical School, Boston, Massachusetts 02115, USA.
authors.forename: Tarun
authors.initials: T
authors.lastname: Mahajan
authors.forename: Anne M
authors.initials: AM
authors.lastname: Dubin
authors.forename: Dianne L
authors.initials: DL
authors.lastname: Atkins
authors.forename: David J
authors.initials: DJ
authors.lastname: Bradley
authors.forename: Kevin M
authors.initials: KM
authors.lastname: Shannon
authors.forename: Christopher C
authors.initials: CC
authors.lastname: Erickson
authors.forename: Wayne H
authors.initials: WH
authors.lastname: Franklin
authors.forename: Frank
authors.initials: F
authors.lastname: Cecchin
authors.forename: Charles I
authors.initials: CI
authors.lastname: Berul
mesh_terms: D002648:Child; D017147:Defibrillators, Implantable / Q000523:psychology* / Q000706:statistics & numerical data*; D004868:Equipment Failure / Q000706:statistics & numerical data*; D005260:Female; D006801:Humans; D007221:Industry / Q000706:statistics & numerical data; D008297:Male; D010353:Patient Education as Topic / Q000706:statistics & numerical data*; D011358:Product Surveillance, Postmarketing / Q000706:statistics & numerical data*; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration