The device had been recalled, but the patient was not notified, and now the FDA is on the hot seat for the approval process. Devices do get recalled unfortunately, and this was one from Medtronic. There is no way she can sue either as the the company did not disobey the FDA. One congressman is blaming the FDA for their lack of funds and resources to adequately approve such products and devices. BD
Robb recounted her terror before a Senate committee today, saying the electric jolts "felt as if a cannon was being repeatedly shot at my chest at close range." "Here's a woman who is basically being electrocuted by a device that had been recalled by a company that didn't even tell her," said Leahy.
A faulty wire caused the malfunction under her skin, which meant Robb felt like she was being repeatedly electrocuted. Making matters worse, when she got to the hospital, Robb found out the defibrillator had been voluntarily recalled two months earlier.
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