Little Girl with St. Jude Riata Defibrillator Lead Faces UncertaintySep 10, 2012 | Parker Waichman LLP
The dilemma faced by people who rely on the St. Jude Riata or Riata ST implanted cardiac defibrillator leads is not just limited to older patients.
In a New York Times report this week, the dangers posed by these defective and recalled defibrillator leads are also being faced by younger patients, including a New York 9-year-old who suffers from an inherited condition that requires her to have a pacemaker for her heart to function properly.
Avery de Groh currently relies on the St. Jude Riata leads connecting her heart to an implanted defibrillator. The leads were recalled late last year, meaning she again faces a risk of suffering a life-threatening injury. de Groh was previously implanted with faulty Medtronic leads that caused her to suffer unnecessary shocks, nine in total, that nearly caused her to die.
Following those malfunctions, the then 4-year-old girl was implanted with the St. Jude Riata leads. In December of last year, the Food and Drug Administration announced their recall from the market due to a design defect that caused the conductive ends of the leads to break free from the insulation covering them, known as “inside-out” abrasion. This resulted in the leads misfiring or sending shocks when they weren’t necessary, putting patients at risk of fatal injuries.
At least 20 deaths have been blamed on the defective St. Jude leads and that number could rise as people debate whether or not to have them replaced.
Tens of thousands of people like de Groh still face a dilemma concerning the safety of their defibrillator lead. Despite the recall, many patients may not suffer this malfunction and the risk of replacing the wires could cause them to suffer more injuries. Since the recall, the FDA has struggled with what to recommend to patients who rely on the Riata and Riata ST leads daily to maintain a normal heart rhythm.
In the interim, the agency recommends people relying on the defective and recalled leads to have annual X-rays to determine if the leads are showing any signs of the abrasion that caused them to be removed from the market. These images will help doctors determine the best path for patients and that’s what de Groh’s mother told the New York Times she was doing.
Still, not all factors in what causes the Riata and Riata ST lead to malfunction are known so many others have decided not to wait for the leads to fail or to even show signs of wear. According to the report, some patients have opted for the surgery that would replace the leads with newer devices.
St. Jude has since released a new line of defibrillator leads, the Durata, that features a new coating on the conductive ends that’s allegedly not prone to the same failures that led to the recall of its predecessor.