News for June, 2009

FDA issues Class I recall for faulty pacemakers

The Food and Drug Administration (FDA) has issued an alert to patients just two weeks after Medtronic, Inc. sent separate letters to health care professionals and patients worldwide warning that thousands of its pacemakers could have faulty wiring that can cause the medical devices to work improperly or not work at all. This defect could have potentially deadly consequences for patients with the devices.

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Congressional hearings continue on Medical Device Safety Act

capitol dome 100x100The House Energy and Commerce Health Subcommittee continues to debate the Medical Device Safety Act of 2009, with the announcement of a June 18 hearing on the matter. The bill proposes to overturn the Supreme Court ruling of Riegel v. Medtronic, Inc., which prevents consumers who have been hurt by defective medical devices to sue the device’s maker if the devices have been approved by the Food and Drug Administration (FDA). The class includes medical devices such as cardiac defibrillators, pacemakers, replacement heart valves, coronary artery stents and pre-filled syringes.

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Man says faulty defibrillator felt like being kicked by horse

kicking horse 100x100“It felt like having a horse inside you trying to kick its way out of your chest,” says Bill Storms of Delaware, Ohio, describing what it felt like when the Medtronic cardiac defibrillator implanted in his chest began malfunctioning and sending electrical jolts through his body. The 38-year-old truck driver said his device misfired 138 times over a five-hour period before the device was eventually turned off.

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