title: Early detection of an underperforming implantable cardiovascular device using an automated safety surveillance tool.
abstract: BACKGROUND
  Postmarket medical device surveillance in the United States depends largely on voluntary reporting of adverse events. Consequently, early safety signals may be missed, exposing patients to potentially hazardous products. The aim of this study was to assess the feasibility of using an automated safety surveillance tool to detect early signals that a marketed implantable cardiac device was underperforming.
  
  
  RESULTS
  For this purpose, we performed simulated prospective monthly full-cohort and propensity-matched comparative survival analyses on our 3-center database of Sprint Fidelis and Quattro Secure implantable cardioverter-defibrillator leads, using a commercially available automated surveillance tool that was preset to trigger an alert if the log rank probability value was <0.05. During the study, 84 of 1035 Fidelis (8.1%) and 23 of 1675 Quattro (1.4%) leads failed. The simulated full-cohort analysis triggered a sustained alert for Fidelis leads beginning 13 months after the first implant and 2 years before Fidelis leads were removed from the market. Of the 1035 patients who had Fidelis leads, up to 969 (93.6%) were successfully matched to Quattro patients. In the propensity-matched analysis, the alert triggered 22 months after the first Fidelis implant and more than 1 year before the lead was recalled.
  
  
  CONCLUSIONS
  An active automated safety surveillance system could have identified this implantable cardiovascular device problem substantially sooner than was achieved through existing postmarket surveillance methods. Such a tool, when applied to clinical registries and remote monitoring databases, may limit the exposure of large populations to underperforming and potentially hazardous cardiovascular devices.
authors.affiliation: Minneapolis Heart Institute Foundation, 920 E 28th St, Minneapolis, MN 55407, USA. rhauser747@aol.com
authors.forename: Robert G
authors.initials: RG
authors.lastname: Hauser
authors.forename: Andrew S
authors.initials: AS
authors.lastname: Mugglin
authors.forename: Paul A
authors.initials: PA
authors.lastname: Friedman
authors.forename: Daniel B
authors.initials: DB
authors.lastname: Kramer
authors.forename: Linda
authors.initials: L
authors.lastname: Kallinen
authors.forename: Deepa
authors.initials: D
authors.lastname: McGriff
authors.forename: David L
authors.initials: DL
authors.lastname: Hayes
mesh_terms: D015331:Cohort Studies; D017147:Defibrillators, Implantable; D042241:Early Diagnosis; D004868:Equipment Failure; D004869:Equipment Safety; D006801:Humans; D011446:Prospective Studies; D016019:Survival Analysis