WHILE QUESTIONS LINGER OVER GUIDANT’S THREE-YEAR DELAY IN NOTIFYING DOCTORS OF THE RISK ITS IMPLANTED DEFIBRILLATORS COULD SHORT-CIRCUIT, CARDIOLOGISTSJun 19, 2005 | www.Newsinferno.com
In hindsight, there is no doubt that, while Guidant Corporation maintained its internal heart defibrillator (the Ventak Prizm 2 DR) was safe and extremely reliable, it was fully aware of an electrical problem in thousands of those devices which could cause them to short-circuit when needed.
On May 24, Guidant disclosed for the first time that it had waited three years before disclosing it had been aware of the electrical problem that had caused some 28 of these defibrillators to malfunction. The revelation came in the form of an alert to physicians which was not issued until Guidant learned that The New York Times was about to publish a story on the defibrillator.
In March, a 21-year-old college student, Joshua Oukrop, who required a defibrillator because he suffered from a genetic heart disease, died while on a spring break bicycling trip. These events prompted an investigation by the FDA.
As the story developed, however, the number of potentially defective defibrillators still in use reached almost 50,000; the 28,900 with the electrical problem and another 21,000 which could malfunction due to a computer memory error (the Vertak Prizm AVT, Vitality AVT, Renewal 3 AVT, and Renewal 4 AVT ICD). There had been 2 reports of failures associated with these other models. Neither report involved injury or death.
Then, a third problem came to light with respect to another potential short-circuit risk associated with the Contak Renewal (Model H135) and the Comtak Renewal 2 (Model H155). Out of those 16,000 devices, 15 reports of failures had been received including one involving a death on May 30.
On Friday, Guidant issued recalls for all of these devices. The Ventak Prizm 2 DR should be monitored and will be replaced if necessary by Guidant at no charge. For the models with potential memory errors, Guidant is recommending an in office programming change that can reduce the risk until Guidant is able to design a software solution. The remaining devices should be monitored at three-month intervals and undergo a complete trouble-shooting procedure if a yellow warning screen appears on the programmer.
Many experts are now questioning a monitoring system which essentially leaves the question of disclosure, with respect to potential flaws in such critical medical devices, entirely to the manufacturer.
The current system is seen as problematic for a number of reasons. First, the ultimate decision may be based not only on patient safety issues but, also, on extraneous considerations such as potential legal liability and loss of market share to competitors. Second, the FDA does not collect comprehensive data on these devices after they are approved. Finally, hospitals and doctors do not notify the FDA about all device-related problems. Reporting of such incidents is spotty at best.
Currently, a group of doctors who treat heart-related problems are considering setting up a task force to develop proposed guidelines with respect to physician alerts.
In the Guidant case, it seems clear that the impending expose by the New York Times, instead of 2 deaths and 45 reported failures, prompted the manufacturer’s belated revelations. Attorneys who are suing Guidant as well as many of their clients see Guidant’s long delay as a damaging admission by the company which they believe must be held accountable for its actions.
None of this, however, even begins to address the problem of some 50,000 heart patients with implanted defibrillators being very jittery about their safety. Simply stated, since the purpose of an electrical heart defibrillator is to shock an irregularly beating heart back into proper rhythm, any malfunction can be extremely serious. In fact, if normal heart rhythm is not restored, death will result within minutes.
For this reason, heart specialists are anticipating a flurry of office visits and telephone calls from patients who have one of the recalled defibrillators. Doctors are advising patients to remain calm and not to assume that their particular device must be removed and replaced immediately.
The FDA is advising affected patients to consult with their doctors to discuss the recall especially if they have recently received a defibrillator shock.