Boston Scientific Corp. has recently warned doctors that a batch of 996 Guidant defibrillators may fail. In 2005, Guidant recalled over 100,000 of its defibrillator units. This new announcement may lead to another recall.
Guidant became aware of problems with its defibrillator in 2002, and began making changes to the device. They did not alert doctors to the problem, and they continued to sell the existing defective defibrillators. In May of 2005, they finally revealed the defect to doctors, the night before the New York Times reported that 21-year-old man had died because his Guidant Defibrillator short circuited.
Surgery to replace defective defibrillators can be dangerous. Guidant claimed that they originally withheld information about the defective units from doctors because they felt the risk of replacement surgery was greater than the risk of the device malfunctioning. This does not explain why they continued to sell the existing faulty units.
Boston Scientific bought Guidant Corp. after the problems with the dangerous product were revealed. It is believed that Guidant hid problems with its defibrillators in order to keep stock prices up. Johnson & Johnson had planned to buy Guidant, but lowered its offer when the problems came to light. Boston Scientific purchased Guidant for $27.5 billion.
The most recent defect is a faulty capacitor. This can cause the battery to run down and the unit to simply stop working leaving patients unprotected. So far, 30 defective units have been removed from patients, and Boston Scientific suspect that 46 faulty units may still need to be removed. The defective units are all part of one batch of 996 defibrillators manufactured around March, 2005. Boston Scientific says it is currently fighting 306 defibrillator lawsuits and expects the future number of patients suing to reach 3,000.
Past problems with Guidant defibrillators include short circuiting, computer memory problems, and a faulty magnetic switch. Patients who have the implanted device rely on it to detect irregular heart rhythms and shock the heart, restoring a normal heartbeat. When the device fails to respond and administer the shock, patients can die of cardiac arrest. If the unit delivers an unneeded shock patients can also be injured or die.
Implanted defibrillators can and do save lives. It is estimated that thousands, possibly millions of people could be saved from cardiac arrest leading to death, by properly functioning implanted defibrillators. However, when these devices fail patients are left without the protection that they believe they have. This is worse than not having the device at all.