title: Deaths caused by the failure of Riata and Riata ST implantable cardioverter-defibrillator leads.
abstract: BACKGROUND
  Riata and Riata ST leads (St Jude Medical, Sylmar, CA) were recalled in 2011. These leads are prone to externalized conductors. However, it is electrical malfunctions that may result in serious adverse events, including death.
  
  
  OBJECTIVE
  To assess the deaths of patients with Riata and Riata ST leads that have been reported to the Food and Drug Administration to determine whether they were due to lead malfunction. A similar analysis was performed for Quattro Secure leads (Medtronic, Inc, Minneapolis, MN).
  
  
  METHODS
  In February 2012, we searched the Food and Drug Administration's Manufacturers and User Facility Device Experience database for deaths associated with Riata, Riata ST, and Quattro Secure leads. A lead-related death was a sudden or unexpected death accompanied by evidence of lead malfunction; an indeterminate death was a death that was nonsudden or evidence of lead malfunction was not provided; a not lead-related death was a death that was nonsudden and/or there was no evidence that the lead contributed to the patient's demise.
  
  
  RESULTS
  The Manufacturers and User Facility Device Experience database search found 133 deaths; of these, 22 were caused by Riata or Riata ST lead failure and 5 were caused by Quattro Secure lead failure. Riata and Riata ST lead failure deaths were typically caused by short circuits between high-voltage components. No death was due to externalized conductors.
  
  
  CONCLUSIONS
  Riata and Riata ST implantable cardioverter-defibrillator leads are prone to high-voltage failures that have resulted in death. These failures appeared to have been caused by insulation defects that resulted in short circuiting between high-voltage components. Externalized conductors were not a factor in these deaths.
authors.affiliation: Minneapolis Heart Institute Foundation, Minneapolis, Minnesota 55407, USA. rhauser747@aol.com
authors.forename: Robert G
authors.initials: RG
authors.lastname: Hauser
authors.forename: Raed
authors.initials: R
authors.lastname: Abdelhadi
authors.forename: Deepa
authors.initials: D
authors.lastname: McGriff
authors.forename: Linda Kallinen
authors.initials: LK
authors.lastname: Retel
mesh_terms: D001145:Arrhythmias, Cardiac / Q000401:mortality*; D002423:Cause of Death; D016208:Databases, Factual; D017147:Defibrillators, Implantable / Q000706:statistics & numerical data; D004553:Electric Conductivity; D004567:Electrodes, Implanted; D004867:Equipment Design; D004868:Equipment Failure; D005466:Fluorocarbons; D006801:Humans; D057053:Safety-Based Medical Device Withdrawals; D011138:Polytetrafluoroethylene / Q000031:analogs & derivatives
chemical_list: D005466:Fluorocarbons; C040378:poly(ethylene-tetrafluoroethylene); D011138:Polytetrafluoroethylene