A defibrillator is a device that applies an electric pulse to a patient's heart in response to an irregular heartbeat, to stop the fibrillation of the ventricular muscle. The shock is designed to cause the heart to resume a normal rhythm. An implanted defibrillator relies upon batteries, and typically must be replaced every five to six years as the batteries are depleted.
The Guidant Defibrillator was a device that was implanted into a cardiac patient, under the skin of the chest, to detect an irregular heartbeat and to automatically administer an electric shock. In November, 2002, Guidant Corporation announced that it had defected a flaw in some of its defibrillators for its Ventak Prizm 2 DR Model 1861 (also known as the Prizm 2 DR). The company indicated that it had corrected the defect for devices manufactured after April, 2002. They also further refined their defibrillators in November of 2002, by adding additional insulation.
Following the death of a young patient who relied upon a Guidant defibrillator, Guidant Company revealed that the problem it had corrected was an electrical defect that could cause a defibrillator to short-circuit. Guidant argued that, with its improved manufacturing process, there have been no short-circuits of any defibrillators made subsequent to that announcement. Guidant admits selling the previously manufactured devices under the belief that they were reliable.
Thousands of cardiac patients still rely upon Guidant defibrillators manufactured prior to April, 2002.
- Guidant asserts that the failure rate for those defibrillators is comparable to the failure rate for defibrillators produced at a later date, and that the risks of replacement surgery exceed the risk of continued reliance upon an older defibrillator.
- Others point to some unexpected deaths among defibrillator users, and question if that advice is sound, particularly for high risk patients.
- Some consumer advocates question Guidant's record, following the recall of its Ancure Endograft Device for treatment of abdominal aortic aneurisms.
Lawyers for patients who received Guidant defibrillators alleged that Guidant Corporation continued to sell defective defibrillators even after April, 2002, and that as a consequence heart patients continued to receive implants of defective defibrillators during subsequent months. Lawyers filed a class action against Guidant Company in relation to the manner in which it handled the defibrillator problems.
Guidant was later acquired by Boston Scientific Corporation which, in 2007, settled approximately 4,000 legal claims relating to the defibrillator for $195 million.