Guidant Defibrillator FAQ
Q: What is a defibrillator?
A: A defibrillator is a device surgically implanted in persons who have a type of heart disease that creates the risk of a life-threatening heart arrhythmia (abnormal rhythm). These devices deliver an electrical shock to the heart to restore normal heart rhythm.
Guidant Corporation makes defibrillators, which have recently been subject to a recall. In April 2006, Guidant Corporation was acquired by Boston Scientific.
Q: Why were Guidant defibrillators recalled?
A: In June 2005, the U.S. Food and Drug Administration (FDA) issued a nationwide notification of recall of certain Guidant implantable defibrillators and cardiac resynchronization therapy defibrillators. The FDA announced that certain devices are subject to different failures, which could result in their inability to deliver an electrical shock during episodes of arrhythmia.
More recently, in June 2006, Boston Scientific issued another recall on certain defibrillators. Boston Scientific/Guidant has confirmed five reports of device malfunction among some 27,200 patients worldwide who have had these devices implanted.
Q: Which devices are affected by the recalls?
A: The Guidant defibrillators affected by the June 2005 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
In June 2006, Boston Scientific announced a recall on the following defibrillators:
- Some Insignia and Nexus pacemakers
- CONTAK RENEWAL TR and TR 2 cardiac resynchronization pacemakers
- VENTAK PRIZM 2, VITALITY, and VITALITY 2 ICDs (implantable cardioverter defibrillators)
Q: Have any deaths been reported as a result of a defibrillator malfunction?
A: In June 2005, the FDA received reports of two deaths, which are suspected to be associated with a Guidant defibrillator malfunction.
In June 2006, Boston Scientific/Guidant reported one malfunction, which occurred at the time of implantation. In four other cases, the patients needed device replacements. In two of these cases, the patients lost consciousness when their devices malfunctioned. No deaths have been reported.
Q: What should I do if I have a Boston Scientific/Guidant defibrillator implanted?
A: In June 2005, the FDA recommended taking the following steps if you might be affected by a faulty defibrillator:
- Contact your doctor to determine if you have an affected product
- Keep regular doctor appointments
- Contact your doctor if you feel an electrical shock
- Go to your doctor or the emergency room if there is audible beeping, which is a sign that the device might be damaged.
In the more recent recall, Boston Scientific sent letters to doctors and patients, warning and advising that patients see their doctors as soon as possible.
Q: What should I do if I think I have been injured by a faulty defibrillator?
A: If you or a loved one have been implanted with a Guidant defibrillator and are experiencing any unusual medical conditions, you should contact your doctor immediately. You may also wish to meet with an experienced attorney to discuss your options and to protect your right to a legal remedy for any injuries caused by a Guidant defibrillator.