Bueno was implanted with a St. Jude Medical ICD with a Riata lead in July 2006, but the day he was released from the hospital he experienced chest pain.
“The wires had come out and had poked his heart,” Aurelia says. “They did x-rays and found internal bleeding.”
Bueno underwent a second surgery to fix the problem and spent a month in the hospital, including seven days in the intensive care unit. Still, his troubles continued. He suffered shocks from the device when his heart didn’t need to be jolted back to life, including one that left him unconscious.
The faulty device, which was the subject of a Class I recall in 2011, was finally removed and a device with three new leads implanted in a third surgery in September 2013, but the psychological and economic burden of Bueno’s ordeal has been heavy. Before removal, he was beset by fears that the device would fail. The couple’s construction business has failed because Bueno’s health problems kept him off the job for two years.
Aurelia says they are neck deep in debt and are surviving on disability payments and food stamps. Her husband can barely walk a block now. It’s a shocking turn of events for a man who was once so strong that people often asked if he played in the NFL.
Bueno’s lawsuit against St. Jude Medical alleges that the company didn’t follow good manufacturing practices in developing the Riata lead. In January 2013, FDA sent St. Jude a warning letter about violations related to the Sylmar, CA, plant where the Riata lead and other devices were made. The violations were resolved just this past July.
“Patient safety is St. Jude Medical’s highest priority. While we are unable to comment on ongoing litigation, we remain dedicated to developing technology and products that save and improve the lives of patients around the world,” a St. Jude spokeswoman said via E-mail.
When asked what she would say if she could talk to St. Jude executives, Aurelia is stunned into silence. “I don’t have words to tell them,” she mumbles through tears. Later, when she recovers, she adds: “I would like them to take responsibility for what they [have] done because it was their fault.”