Linda M Kallinen Retel

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AIM The purpose of this study was to determine if Optim™, a unique copolymer of silicone and polyurethane, protects Riata ST Optim and Durata implantable cardioverter-defibrillator (ICD) leads (SJM, St Jude Medical Inc., Sylmar, CA, USA) from abrasions that cause lead failure. METHODS AND RESULTS We searched the US Food and Drug Administration's (FDA's)(More)
BACKGROUND Conductor fractures may affect the performance of implantable cardioverter-defibrillator leads. During routine surveillance of returned product analyses (RPAs) in the Food and Drug Administration's Manufacturers and User Facility Device Experience database, we found a number of conductor fractures in small diameter implantable(More)
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