Device name: Riata Defibrillator Lead
Manufacturer: St. Jude Medical
Approved uses: Approved for use in a defibrillator system with one or more leads, or wires, connecting the device to the heart for the purpose of defibrillation in the event of cardiac arrest in those at risk.
• Reportedly, the lead wire has perforated the heart of a number of patients, requiring surgical removal.
Related topics: Medtronic Defibrillator Lead
St. Jude Riata Defibrillation Lead
In November 2007, reports emerged that St. Jude Riata Defibrillator Lead wires had malfunctioned and perforated the hearts of some patients. That month, the medical journal Pace published a report detailing four instances where the St. Jude Riata Defibrillator Lead wire detached and perforated the heart wall. In one instance, the defective St. Jude Riata Defibrillator Lead wire nearly poked through a patient’s skin.
The affected models include: Epic DR/HF (V-233/V-337/V-338), Epic Plus DR/VR/HF(V-236/V-239/V-196/V-239T/V-239T/V-196T/V-350), Atlas DR (V-242), and Atlas Plus DR/VR/HF (V-243/V-193/V-193C/V-340/V-341/V-343).
St. Jude Riata Defibrillator Recall
With a flood of reports on the recent increase of St. Jude Medical Riata Defibrillator Lead wire malfunctions gracing newspapers and news programs, those with internal cardiac defibrillators, (ICDs), are likely feeling their heart skip a bit. But merely hoping that their defibrillator works to shock it back to its regular rhythm is a risk that is too dangerous to take. However, how is an individual to know if they are the victim of a St. Jude Medical Riata Defibrillator Lead malfunction? It has been discovered that individuals do not know until cardiac arrest or death occurs if their defibrillator is functioning properly.
The St. Jude Medical Riata Defibrillator Case and Statistics
St. Jude Medical has refused to issue a recall of its Riata Defibrillator Lead, even though reports have run rampant on the lead wires malfunctioning and causing cardiac arrest, perforation of the heart, and, unfortunately, death in some instances. The Federal Drug Administration has also refused to step in and recall the defibrillator, even though it has been reported in the news and in respected scientific journals that the St. Jude Medical Riata Defibrillator Lead is causing those with the device to be at an ever-increasing risk for malfunctioning issues.
While it has been reported that the St. Jude Medical Defibrillator Lead is a risk, St. Jude Medical officials insist that their defibrillator lead poses no more a risk of malfunctioning than other defibrillator leads on the market. However, it has been reported in the news that among several state�s hospitals, including New York and Massachusetts, there has been anywhere from 3.8 percent to 11.8 percent of patients who have had their St. Jude Medical Riata Defibrillator Lead perforate the heart. There is a large margin of error due to lack of reporting in the medical community. It was also reported that the New York Hospital in Queens no longer is using the defective leads. Still, St. Jude claims that their lead has a perforation heart of 0.33 percent.
News reports have surfaced regarding one instance when a woman, who had received the St. Jude Medical Defibrillator Lead, returned for her five-week follow-up visit only for doctors to find perforation had occurred. Her defibrillator implant was not delivering the electric jolt and only through the routine visit did doctors discover this malfunction; otherwise the woman may have not found the error until it was too late.
Outcome and Risks of A St. Jude Riata Lead Malfunction
If a St. Jude Medical Riata Defibrillator Lead malfunctions, several outcomes are possible, all of which result in immediate medical attention. Because the defibrillator lead is responsible for shocking the heart back into rhythmic regularity, if the lead wires malfunction, the risk of cardiac arrest is increased. A defibrillator lead wire can detach from the device or break and therefore, is unable to sense irregular heart rhythms and cannot provide the electric shock therapy that is required to keep a patient alive.
It is also highly possible, as recently reported in the Pace medical journal that if the St. Jude Medical Riata Defibrillator Lead wire detaches or breaks, the wire can pierce the heart wall causing perforation. In one instance, the journal reported that the wire was nearly penetrating the skin of a patient.
Perforation of the heart is a serious condition, which is why individuals who have undergone the surgical procedure and received a St. Jude Medical Riata Defibrillator should not only seek medical attention but should receive an attorney consultation to determine damages that should be retrieved in a court of law from the manufacturers of the malfunctioning defibrillator lead.