The mother of a little girl who has already been through one painful ordeal because of a defective defibrillator lead wire now lives in fear that the St. Jude Riata defibrillator lead her daughter received as a replacement could go bad as well.
“When I think about how scary it was for her,” 9-year-old Avery de Groh’s mother recently told The New York Times, “I feel like, give that to me, and let her be fine.”
Like her mother and two younger siblings, little Avery was born with Long QT syndrome, which can cause a heart to beat abnormally. As a result, Avery received an implantable cardiac defibrillator at a very young age. One night in 2007, the Medtronic lead wire that connected the defibrillator to Avery’s heart failed, sending nine painful electric shocks through her body in less than 30 minutes. Then just 4, Avery underwent a risky surgical procedure to have the malfunctioning Medtronic lead replaced with the Riata, a lead wire manufactured by St. Jude Medical, Inc.
Unfortunately, Avery’s worries weren’t over. As we’ve reported previously, St. Jude stopped selling the Riata and Riata ST defibrillator leads in late 2010, and warned doctors not to use them because they were poking through their insulation. Such a defect can cause a defibrillator to emit unnecessary shocks to a patient’s heart, and even worse, fail to emit a life-saving electrical impulse to the heart when it’s needed. In December 2011, the U.S. Food & Drug Administration (FDA) deemed St. Jude’s action a Class I medical device recall, its most serious type of recall. While St. Jude initially said that only 1% of patients were in danger of experiencing problems with their Riata lead, a more recent analysis put the number closer to 19%.
Just last month, the FDA recommended that patients with Riata leads undergo regular x-rays or other imaging tests to check for abnormalities in the insulation surrounding the wire. However, the FDA is not recommending that patients automatically have the wires removed if their imaging tests indicate problems. Instead, the agency says each patient should be evaluated individually to determine if the benefits of lead removal outweigh its risks.
It is estimated that 128,000 people have Riata leads implanted in their body. Avery is one of them. Her mother told The New York Times that she is angry that the FDA never contacted patients directly about the Riata’s problems. Mrs. de Groh only learned of the issues when she read about them last month in a newsletter issued by a patient advocacy group.
In addition to its recommendations that all patients with the Riata lead undergo screening, the FDA also ordered St. Jude to conduct additional studies on the Riata, as well as its Durata lead, the wire that replaced the Riata. According to The New York Times, the Durata is made with a new coating that the company said seemed to have fixed the issue. But according to The New York Times, a new study published over the summer indicated that the Durata could suffer from the same problems.
That’s just another worry for the de Groh family, since Avery’s 5-year-old brother, Oliver, was implanted with a Durata lead when he received his own defibrillator.