Ross
Well-known member
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
FDA and Guidant Corporation notified health care providers and patients of
the recall of certain implantable defibrillators and cardiac
resynchronization therapy defibrillators. These devices, surgically
implanted in persons who have a type of heart disease that creates the risk
of a life-threatening heart arrhythmia (abnormal rhythm), can develop an
internal short circuit without warning, resulting in the devices' inability
to deliver an electrical shock during episodes of arrhythmia -- which could
lead to a serious, life-threatening event. There have been two deaths
reported to FDA suspected to be associated with this malfunction. The
devices affected by this notification are:
PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002
CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004
CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004
Read the complete MedWatch 2005 Safety summary,including the link to the FDA
Press Statement, at:
http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Guidant
FDA and Guidant Corporation notified health care providers and patients of
the recall of certain implantable defibrillators and cardiac
resynchronization therapy defibrillators. These devices, surgically
implanted in persons who have a type of heart disease that creates the risk
of a life-threatening heart arrhythmia (abnormal rhythm), can develop an
internal short circuit without warning, resulting in the devices' inability
to deliver an electrical shock during episodes of arrhythmia -- which could
lead to a serious, life-threatening event. There have been two deaths
reported to FDA suspected to be associated with this malfunction. The
devices affected by this notification are:
PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002
CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004
CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004
Read the complete MedWatch 2005 Safety summary,including the link to the FDA
Press Statement, at:
http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Guidant
