You can find it here.
According to the site:
"Guidant has informed [the FDA] that six (6) additional clinical occurrences (of which FDA has 4 confirmed reports) exhibiting this failure mode worldwide have been reported for the Contak Renewal® and Renewal® 2 devices since our July 14, 2005 PPHN, for a total of 21 clinical failures, including 3 patient deaths, worldwide as of October 7, 2005. You should take these failures into account as you continue to follow the patients who retain either device."
