Riata and Riata ST leads (St. Jude Medical, CA) were recalled in 2011. These leads are prone to externalized conductors. However, it is electrical malfunctions, which may result in serious adverse events, including death.
Riata and Riata ST ICD leads are prone to high-voltage failures that have resulted in death
Objective:The purpose of this study was to assess the deaths of Riata and Riata ST patients that have been reported to the FDA in order to determine if 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 FDA’s MAUDE 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 non-sudden, or evidence of lead malfunction was not provided; a not lead-related death was a death that was non-sudden, and/or there was no evidence that the lead contributed to the patient’s demise.
Results:The MAUDE search found 133 deaths; of these, 22 were caused by Riata or Riata ST lead failure, and 5 were caused by Quattro Secure failure. Riata and Riata ST deaths were typically caused by short-circuits between high voltage components. No death was due to externalized conductors.
Conclusion:Riata and Riata ST ICD leads are prone to high-voltage failures that have resulted in death. These failures appeared to be caused by insulation defects that resulted in short-circuiting between high-voltage components. Externalized conductors were not a factor in these deaths.