FDAnews Device Daily Bulletin

CRUCIAL TO INFORMED CONSENT: CENTER-SPECIFIC RATES FOR 'ADVISORY-DEVICE' REPLACEMENT COMPLICATIONS

May 22, 2006
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Investigators at a single center observed a 1.24% risk of major complications leading to surgical replacement of pulse generators for pacemakers or implantable cardioverter-defibrillators (ICDs), a rate that can help guide discussions with patients when their devices are the target of safety-alert or recall advisories, according to investigators reporting at the Heart Rhythm Society 2006 Scientific Sessions.

Heart Wire (http://www.theheart.org/article/701175.do)