Implantable defibrillators that are intended to save lives may malfunction and cause injury to the very people intended to be helped. There are increasing reports that leads used in Medtronic and St. Jude implantable defibrillators –specifically in the Medtronic Sprint Fidelis leads and St. Jude Riata lead wires– have fractured or separated, perforating the heart walls, causing the device to fail to deliver a needed shock, or deliver repeated unnecessary shocks. Patients are now being faced with the panic and anxiety of living with a device that may malfunction or the suffering and expense of enduring procedures to replace or supplement these leads.
Implantable defibrillators monitor a patient’s heart rhythm and provide an electrical shock when that rhythm is abnormal. The lead is a thin wire that extends from the device and is attached to the heart to deliver the electrical impulse from the defibrillator. If a lead detaches or breaks, the device may not sense the need for a shock or may be unable to deliver the shock, or may deliver an unnecessary shock, and sometimes multiple times. If the lead wire detaches, it may perforate the heart wall, causing a fatal condition where the heart bleeds and the accumulation of blood puts pressure on the heart preventing the heart from properly functioning. Any problems that are encountered with leads are very serious as removing or replacing the leads requires risky surgery – something that most patients understandably try to avoid.
In October 2007, Medtronic recalled its Sprint Fidelis leads amidst reports that patients were receiving unnecessary shocks – some having reported being shocked upwards of 20 to 30 times in the same episode. Medtronic–the nation’s largest maker of implanted heart devices–acknowledged five patient deaths linked to breaks in its Sprint Fidelis Lead wires prior to the recall. Medtronic has used the defective Sprint Fidelis Leads since 2004 and there are reported to be more than 172,000 in use in the United States.
St. Jude’s Riata leads have not been recalled, but several cases of injury have been reported. There are reports that the Riata leads are detaching from the heart and puncturing holes in the hearts of defibrillator patients. If the lead is not attached to the heart, it also creates the concern that he device will fail to deliver a necessary shock.
Defibrillator patients should consult with their doctors to discuss any problems that may be associated with the Medtronic Sprint Fidelis and the St. Jude Riata leads. Shipman & Wright, LLP is investigation legal claims on behalf of patients who have suffered injury and harm due to the malfunctioning of their defibrillator leads or who are now living with the anxiety of having recalled leads used with their device.
For more information on this subject, please refer to the section on Drugs, Medical Devices and Implants.