Guidant Device Information
By Garrison Scott, P.C.
What is an implanted defibrillator?
An implantable defibrillator is an electronic device implanted in the body and intended to prevent cardiac arrest from severe ventricular tachycardia. An electrode is connected between the heart and a tiny computer in the defibrillator. This computer monitors the heartbeat, and if it detects an arrhythmia, it activates a built-in pacemaker to restabilize the heart's rhythm. If that fails, it delivers a small defibrillating electrical jolt to the heart. In an extreme case, it resorts to a far stronger jolt to reset the heart rate.
Who is Guidant?
Guidant refers to itself as a world leader in the design and development of cardiovascular medical products. It is a major manufacturer of implantable medical devices, including defibrillators. Its corporate headquarters are in Indianapolis, with major operations in California, Minnesota, Texas, Washington, Puerto Rico and Ireland. Guidant is in the process of being acquired by Johnson & Johnson, which has its headquarters in New Jersey.
What is the problem with Guidant defibrillators?
On June 17, 2005, Guidant announced that it was recalling 50,000 of its implantable defibrillators, 38,000 of which are in use in the United States. The defibrillators can short-circuit, causing them to fall and not work as intended. The company has received reports of the device malfunctioning at least 45 times, causing at least two deaths. Guidant came under fire earlier this spring after reports that it had failed to alert physicians about potential problems with one of the defibrillator models, the Ventak Prizm 2 DR. A 21-year-old Minnesota college student died in March when his defibrillator short-circuited while he was mountain biking in Utah. A second death has been linked to another model.
What models are defective?
ICDs (implantable cardioverter defibrillators)
- Contak Renewal (Model H135), manufactured on or before August 26, 2004
- Contak Renewal (Model H155), CRT-D, manufactured on or before August 26, 2004
- Contak Renewal 3 (all model numbers)
- Contak Renewal 4 (all model numbers)
- Ventak Prizm 2 DR (Model 1861), manufactured on or before April 16, 2002
- Ventak Prizm AVT (all model numbers)
- Vitality AVT (all model numbers)
- Renewal AVT (all model numbers)
- Renewal 3 AVT (all model numbers)
- Renewal 4 AVT (all model numbers)
- Renewal RF (all model numbers)
Pacemakers
- Pulsar MAX (Models 1170, 1171, 1270)
- Pulsar (Models 0470, 0870, 0970, 0972, 1172, 1272)
- Discover (Models 1174, 1175, 1273, 1274, 1275)
- Meridian (Models 0476, 0976, 1176, 1276)
- Pulsar Max II (Models 1180, 1181, 1280)
- Discover II (Models 0481, 0981, 1184, 1186, 1187, 1283, 1284, 1285, 1286)
- Contak TR (Model 1241)
- Virtus Plus II (Models 1380, 1480)
- Intelius II (Models 1483, 1484, 1485, 1384, 1385, 1349, 1499)
Who has a claim?
• Anyone with one of the models listed above that failed, resulting in uncontrolled ventricular tachycardia requiring documented medical care, who survived the incident, has a claim for injuries and a claim for the cost of replacing the unit.
• The family of a person with one of the models listed above that failed resulting in death has a claim for wrongful death.
• A person with one of the models above that is replaced or needs to be replaced, has an injury claim and a claim for the cost of replacing the unit.
How do I make a claim or get more information?
Call us toll free at 866-547-0009 or contact us online.
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