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Medtronic Heart Lead Recall
News Article Excerpt

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August 2, 2009
Northwest Herald, "McHenry family takes dispute to U.S. Senate"
Molly DeGroh had never heard her daughter scream so loudly, so intensely before. "She told me that the monsters were attacking her," DeGroh said. "I grabbed her to hug her, and I could feel all the electricity jolting back and forth, cycling through her body." About 10 months before, when she was 2½ years old, Avery had a defibrillator implanted to correct a hereditary disorder called Long QT Syndrome. DeGroh has the same condition, as does her 2-year-old son, Oliver, who also will need a defibrillator.

At the emergency room, a chest X-ray showed that a defibrillator lead was broken, DeGroh said. "It's nearly impossible for a 3-year-old to break that lead from inside of her body," she said. A representative from the manufacturer, Medtronic, confirmed that there was a problem and determined that Avery had been shocked nine times, DeGroh said. About a month later, while Avery was home recovering, Medtronic announced that the company was voluntarily suspending distribution of the lead that had malfunctioned, which DeGroh said caused Avery's painful shocks. But in the meantime, DeGroh said the malfunction led to about $30,000 in medical bills from the replacement surgery. DeGroh said their health insurance company told her that Medtronic was responsible for payment. But Medtronic's product was approved by the Federal Drug Administration, and the way the law is currently written means that the DeGrohs can't sue them in state court.
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