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Deaths Caused By the Failure of Riata and Riata ST Implantable Cardioverter-Defibrillator Leads.
MedLine Citation:
PMID:  22449741     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
BACKGROUND:: 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. 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.
Authors:
Robert G Hauser; Raed Abdelhadi; Deepa McGriff; Linda Kallinen Retel
Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-3-23
Journal Detail:
Title:  Heart rhythm : the official journal of the Heart Rhythm Society     Volume:  -     ISSN:  1556-3871     ISO Abbreviation:  -     Publication Date:  2012 Mar 
Date Detail:
Created Date:  2012-3-27     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101200317     Medline TA:  Heart Rhythm     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Copyright Information:
Copyright © 2012. Published by Elsevier Inc.
Affiliation:
Minneapolis Heart Institute Foundation, 920 East 28 (th) Street, Suite 100, Minneapolis, MN 55407.
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