Defective Defibrillator Patients Not Informed of Recalls
May 16th, 2008 amy
Results of two heart patients surveys indicate that not all folks implanted with defective defibrillators recalled were informed that the devices meant to save their lives might kill them.
Recent recalls of implanted defibrillators have forced some patients to have them removed. The devices deliver jolts to the heart that reset its electrical system when needed. One of the new surveys found that almost one in five heart patients didn’t know about recent recalls of their devices, HeathDay reports. Eighteen percent didn’t know about any pacemaker or defibrillator recall. About half learned about them through the media, and only 24 percent heard through their doctor.
According to Dr. Bruce Wilkoff, director of cardiac and tachyarrhythmia devices at Cleveland Clinic, “There are fundamental problems with even the physician’s understanding of the situation and an appropriate focus on accurate information.”
In October of 2007, Medtronic recalled more defective defibrillators after its Sprint Fidelis lead was linked to at least four deaths. These wires, connecting the defibrillator to the heart, are thinner than most and prone to fracture. The fracturing of these wires can cause the defibrillators to malfunction, sending unnecessary shocks to the patient. And these shocks are severe enough to kill. Other times, the wire fractures and the defibrillator simply stops working. Medtronic Pacemakers had previously been recalled due to a defect causing wires to separate.
